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 rebn1282 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 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 that the wire ¿uncurled inside the catheter¿ was confirmed and the cause appeared to be use related.The product returned for evaluation was a 20ga x 2.25¿ accucath midline catheter.The needle was bent at the exit point of the delivery mechanism, the catheter was partially advanced, and the wire could be observed to be curled at the distal tip of the catheter.No usage residue was observed on the device.Microscopic examination of the catheter and wire revealed that the wire had been pulled against the catheter tip causing the catheter to buckle at that region.Further examination revealed damage to the interior catheter wall at the termination point of the needle bevel.Examination of the wire and needle bevel was unremarkable.The observed state of the wire, and additional catheter damage, are characteristic of re-insertion of the catheter back onto the needle.The product ifu provides warning against this practice as it may damage the catheter and cause insertion failure.
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