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 an hub detachment is confirmed but the exact cause is unknown.Two photo samples of a powerglide catheter and extension set were returned for evaluation.An initial visual observation of the photos revealed the distal end of the extension tubing detached from the male luer connector.A ring of adhesive appears to be visible near the detached end.Based on the description of the reported event and photo samples provided, possible contributing factors include excessive tensile force and insufficient adhesive bonding.The complaint of a detached hub is confirmed but the exact cause could not be determined with the photo samples provided.A lot history review (lhr) of rebv0884 showed no other similar product complaint(s) from this lot number.
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