Catalog Number 383532 |
Device Problems
Burst Container or Vessel (1074); Material Separation (1562)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/10/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).Device evaluated by mfr: 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 the bd nexiva¿ closed iv catheter system's extension tubing "burst" and separated from the cannula during use.The following information was provided by the initial reporter: "product has burst the extension tubing has come away from the cannula".
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Manufacturer Narrative
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H.6.Investigation: a physical sample was not available for investigation but bd was provided with a photo of the defect for evaluation.A review of the device history record was performed for the reported lot, 8304975, and no related quality issues were found during production.Our quality engineer reviewed the provided photo and determined that the extension tubing was disconnected from the winged adapter.Based off the provided photo the engineer was able to verify the reported issue.Without the physical sample available for investigation a definitive root cause could not be identified.However, this was a known issue for the manufacturing facility and it was determined that an insufficient amount of adhesive was being applied to the extension tubing and adapter port.This was causing a weak bond to form causing the tubing to become easily disconnected.Capa#684099 was initiated.
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Event Description
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It was reported that the bd nexiva¿ closed iv catheter system's extension tubing "burst" and separated from the cannula during use.The following information was provided by the initial reporter: "product has burst the extension tubing has come away from the cannula".
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Search Alerts/Recalls
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