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 recq0681 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (recq0681) have been reported from the same facility.
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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 a damaged stylet was confirmed an the cause appeared to be use-related.The product returned for evaluation was one 3cg tls stylet.The sample was received inlaid through a t-lock assembly.The wire had been manipulated within the t-lock septum.The stylet exhibited several kinks within the region of polyimide tubing.Blood residue was observed on the pre-flush hang tag and on the stylet.Microscopic inspection of sample revealed the kinks in the polyimide tubing to have occurred between magnets.No breaks were observed in the stylet.The location of the kinks in the stylet was consistent with damage caused by device manipulation.Such damage can occur if the stylet protrudes from the distal end of the catheter during device insertion and if the stylet is not wetted prior to reinsertion.The blood residue observed on the sample suggested that such damage occurred during attempted device use.A lot history review (lhr) of recq0681 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (recq0681) have been reported from the same facility.
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