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 leak is inconclusive due to poor sample condition.One photo of a safestep infusion set label with ref: lh-0029 and lot: ascps0035 was returned for evaluation.The complaint of a leak could not be confirmed from the photo sample provided.Based on the description of the reported event, possible contributing factors include sharp instrument damage and tensile damage.A lot history review (lhr) of ascps0035 showed no other similar product complaint(s) from this lot number.
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