Device Alert: X-Ray Detectable Swabs May Not Be X-Ray Detectable

A fine example of how problems can befall a medical product. In this case, overzealous zapping (alright, gamma irradiating) one particular lot of an X-Ray detectable swab during manufacture has had the potential effect of causing its X-Ray detectable thread to fall to pieces.

In short

UK competent authority, the MHRA has issued a Medical Device Alert(MDA) pertaining to an X-Ray detectable swab which appears to suffer from stripping out of the radio-opaque strip, thereby presenting the threat that it could be left inside patients and not detectable by subsequent X-Rays.

Background

This situation has emanated from UK company Frontier Multigate, which manufactures gauze swabs containing a radio-opaque strip for the aforementioned purpose. It appears that excessive irradiation dose during manufacturing may have caused shredding of the strip, potentially causing it to disintegrate and no longer produce a viable signal from the swab.

The MDA relates to one specific lot of one particular product as follows:

X-ray detectable gauze swabs, Multi-X 10 cm x 7.5 cm 32 ply. Cat no:82410/S2005. Lot: 12401406

Manufactured by Frontier Multigate

The MDA follows a field safety notice issued by the company in October and calls for the identification, quarantine and return to manufacturer of all affected pieces.

The full MDA can be found here.

published: November 19, 2012 in: Alerts/Adverse Events, Imaging

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