The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.
Based on a review of this information, the following was concluded: the complaint of a damaged powerglide was confirmed and the cause appeared to be use-related.
The product returned for evaluation was one 20ga x 10cm powerglide pro assembly.
The sample was received assembled with the catheter overlaying the introducer needle.
Usage residue were observed throughout the catheter and the needle.
The guidewire extended through the needle and the catheter.
The needle perforated the catheter.
The inner core wire was broken and the outer coil wire was elongated.
Microscopic inspection wire confirmed that the inner wire was broken and the outer was elongated.
The weld tip was intact.
The elongated region appeared to be confined to the region of wire within the needle.
The catheter and guidewire damage were consistent with withdrawal against the needle bevel during attempted insertion.
The product ifu states ¿once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle.
If the catheter needs to be repositioned, either do so without the aid of the needle, or remove both the catheter and the needle as a unit to prevent the needle from damaging or shearing the catheter.
¿ a lot history review (lhr) of rebt1468 showed no other similar product complaint(s) from this lot number.
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The information provided by bard represents all of the known information at this time.
Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
The manufacturer has received the sample and will evaluate.
Results are expected soon.
A lot history review (lhr) of rebt1468 showed no other similar product complaint(s) from this lot number.
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