Catalog Number 367364 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/02/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that bd vacutainer® ultratouch¿ push button blood collection set failed to contain blood or medication.The following information was provided by the initial reporter: "this is a report about a deformed and cracked tubing of wingset pbbcs.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 11/17/2021.H.6.Investigation: seven photos as well as 1 contaminated physical sample were received for review and evaluation.The photos and sample were evaluated and the customer's indicated failure mode of cut (cracked) tubing was observed.Batch number: unknown (lot 1174674 provided but appears to be incorrect based on physical sample, wing marking indicates a different product line) in addition, 30 retention samples from lot 1174674 were subjected to a submerged leak test as well as a visual for cut tubing.All samples passed the tests with no defects observed.The device history record was reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.Bd is able to confirm the customer¿s reported failure from the customer sample and photos received as we were able to duplicate the customer¿s reported failure mode.The root cause of the cut tubing is attributed to the packaging process.H3 other text : see h.10.
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Event Description
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It was reported that bd vacutainer® ultratouch¿ push button blood collection set failed to contain blood or medication.The following information was provided by the initial reporter: "this is a report about a deformed and cracked tubing of wingset pbbcs.".
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Search Alerts/Recalls
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