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 reby1136 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, 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 the guidewire/catheter damage was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 18ga x 8cm powerglide pro midline catheter assembly.The sample was received with the safety mechanism engaged and the catheter detached.The distal segment of the guidewire was detached from the assembly and remained inlaid through the catheter.Microscopic inspection of the guidewire revealed the weld tip to be intact.Inspection of the break in the guidewire revealed a granular fracture surface.Inspection of the split in the catheter revealed a granular fracture surface.Deformation and discoloration were observed in the vicinity of the split.Inspection of the tip of the catheter exhibited deformation.The catheter split characteristics were consistent with tearing type damage which appeared to be caused by contact with the guidewire.It appeared that the guidewire became kinked within the catheter and that subsequent tensile (pulling) stress on the wire caused both the catheter perforation and the guidewire elongation and breakage.Such kinking can occur if the catheter is withdrawn back onto the wire following advancement and if the wire is reinserted into the catheter following removal.A lot history review (lhr) of reby1136 showed no other similar product complaint(s) from this lot number.
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