Catalog Number 381023 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/30/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.Medical device expiration date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that during use of the bd insyte¿ autoguard¿ bc shielded iv catheter the safety mechanism wasn't activate.
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Event Description
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It was reported that during use of the bd insyte¿ autoguard¿ bc shielded iv catheter the safety mechanism was not activate.
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Manufacturer Narrative
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Investigation summary: bd was not able to duplicate or confirm the customers indicated failure as no sample, batch, or lot code was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.The complaint was deemed as mdr reportable therefore a submission will be performed.Shall a sample or lot number become available, the complaint will be re-opened and an investigation will take place.This complaint will be closed at this time.
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Search Alerts/Recalls
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