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 of a damaged guidewire is confirmed but the cause is unknown.Three photo samples of guidewire within a dual lumen powerpicc solo was returned for evaluation.The guidewire was shown to be bent over itself within the catheter in the second photo.The third photo showed the guidewire extended from the distal end of the catheter revealing a kink.Based on the description of the reported event and photo samples provided, possible contributing factors include advancement of guidewire against resistance.As the guidewire was observed to be bent over itself within the catheter and was kinked, the complaint is confirmed.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
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