C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number N/A |
Device Problem
Crack (1135)
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Patient Problem
Chemical Exposure (2570)
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Event Date 01/25/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The manufacturer has received the sample and will evaluate.Results are expected soon.A batch history review (bhr) of asgsfc099 showed one other similar product complaint(s) from this lot number.
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Event Description
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It was reported by the customer, "huber needle leaked, 5fu cassette leaked from the y site farthest from the patient where the tubing was connected.The patient was access monday (january 23, 2023).".
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Manufacturer Narrative
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H11: section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: sample analysis, patient severity, applicable previous investigation(s), complaint and lot history review, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak is confirmed and was determined to be supplier related.One 20 g x 0.75 in.Powerloc infusion set with a non-valved y-site was returned for evaluation.An initial visual observation showed use residue on the returned sample.A large longitudinal crack was observed in the y-site between the two branches of the y-site.A microscopic observation revealed the crack appeared to begin along the knit line of the y-site.The supplier has been notified of this event, and bd is working closely with the supplier to prevent recurrence of the reported event.
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Event Description
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It was reported by the customer, "huber needle leaked, 5fu cassette leaked from the y site farthest from the patient where the tubing was connected.The patient was accessed on monday, on (b)(6) 2023.".
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