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 reaw1020 showed no other similar product complaint(s) from this lot number.
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The following were reviewed as part of this investigation: patient severity, frequency 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 difficulty passing a guidewire through a needle is confirmed and was determined to be use related.One 0.018 in.Guidewire in a plastic hoop, one 0.035 in.J-tip guidewire in a plastic hoop, and one 21 g introducer needle were returned for evaluation.An initial visual observation showed the distal end of the 0.018 in.Guidewire was bent and curved in multiple locations.Blood residue was observed on the 0.018 in.Guidewire and its hoop.The core wires of both guidewires did not appear to be broken during tactile evaluation.A microscopic observation revealed the outer coiled wire of the 0.018 in.Guidewire was unraveled at the most severe bend in the coiled section of the guidewire at the distal end.Some damage was observed on the core to coil interface of the 0.018 in.Guidewire.An attempt was made to pass a non-complaint 0.018 in.Guidewire through the returned 21 g introducer needle and the guidewire was able to be passed with ease.The returned 0.018 in.Guidewire was also able to be passed through the returned 21 g introducer needle, although some difficulty was observed when the bent sections of the guidewire entered the needle cannula.The kinks and bends in the 0.018 in.Guidewire made it difficult to pass the guidewire through the needle and, due to the amount of blood residue and the extent of damage observed, it is most-likely that the guidewire was damaged during use.A lot history review (lhr) of reaw1020 showed no other similar product complaint(s) from this lot number.
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