Model Number 383532 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/13/2019 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that blood leaked from the bd nexiva¿ closed iv catheter system cannula tubing during a blood transfusion once it had started.The following information was provided by the initial reporter: "the incident happened on friday (b)(6) 2019 during a blood transfusion on a patient, a member of staff noticed that there appeared to be blood coming from the cannula tubing once the transfusion had commenced.".
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Event Description
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It was reported that blood leaked from the bd nexiva¿ closed iv catheter system cannula tubing during a blood transfusion once it had started.The following information was provided by the initial reporter: "the incident happened on (b)(6)2019 during a blood transfusion on a patient, a member of staff noticed that there appeared to be blood coming from the cannula tubing once the transfusion had commenced.".
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Manufacturer Narrative
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H.6.Investigation summary our quality engineer inspected the representative samples and photographs submitted for evaluation.Bd received three representative units from catalog number 383532, lot number 9050711.In addition, two photographs were also submitted which displayed the label information.Through the visual examination, the units were inspected for any cuts/slit, damage, or kinks in the device that may cause leakage.A leak test was performed where leakage was not observed.The returned representative units provided for evaluation met and performed per the required manufacturing specifications.There was no physical/mechanical evidence to confirm and support a manufacturing process related issue for the failure stated reported.Examination of the actual product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends h3 other text : see section h.10.
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Search Alerts/Recalls
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