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 recp2192 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 a kink in the polyimide tubing was confirmed and the cause appeared to be use related.The product returned for evaluation was a segment of 3cg stylet.The core wire had been cut 5.3cm proximal of the polyimide transition point and a break in the polyimide tubing was seen near the transition point.Microscopic examination of the fracture features of the polyimide were indicative of a tensile break as the tubing near the proximal end was elongated and discolored.A kink in the polyimide tubing was seen 1.6cm from the distal tip and white residue was seen on the core wire.Microscopic examination of the site showed that the inner support wire contained a complete break at the kink site.Further examination revealed material necking and granularity to the support wire fracture site, both of which were indicative of a tensile break.It was evident from the sample that the device had been both cut and pulled at a point near the polyimide and kink site, which caused damage to both the polyimide tubing and support wire.The complainant had indicated that a ¿section of stylet near where the wire and copper colored portion meet that was missing¿.This was believed to be the gap between the polyimide break ends.From this, it was likely that the kink in the stylet was related to the tensile break of both the polyimide and inner support wire.During the assembly process, each stylet is inspected for damage and procedures are in place to assure the stylet is not damage following assembly into the catheter.A lot history review (lhr) of recp2192 showed no other similar product complaint(s) from this lot number.
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