Model Number 383551 |
Device Problem
Retraction Problem (1536)
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Patient Problem
Abrasion (1689)
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Event Date 06/10/2022 |
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 the bd nexiva¿ closed iv catheter system ¿ single port with maxzero¿ experienced a safety mechanism that would not disengage.The following information was provided by the initial reporter: after the nurse inserted the iv she was retracting the needle and the safety mechanism malfunctioned and had an exposed needle.The exposed needle then scraped across the top of the nurses hand.
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Event Description
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It was reported that the bd nexiva¿ closed iv catheter system ¿ single port with maxzero¿ experienced a safety mechanism that would not disengage.The following information was provided by the initial reporter: after the nurse inserted the iv she was retracting the needle and the safety mechanism malfunctioned and had an exposed needle.The exposed needle then scraped across the top of the nurses hand.
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Manufacturer Narrative
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Investigation summary there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this incident and the findings.A review of the device history record was performed and no quality issues were found during production.
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Search Alerts/Recalls
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