Catalog Number 368652 |
Device Problem
Air/Gas in Device (4062)
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Patient Problem
Perforation of Vessels (2135)
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Event Date 08/04/2023 |
Event Type
malfunction
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Manufacturer Narrative
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D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
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Event Description
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It was reported that during use with bd vacutainer® safety-lok¿ blood collection set with pre-attached holder air bubbles formed and blew patient's vein.There was no additional impact reported.The following information was provided by the initial reporter: customer reports cat # 368652 had started drawing air with the blood, going super, and blew the patient's vein.
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Manufacturer Narrative
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H3.Investigation summary: bd had not received samples or photos for investigation.Therefore, 30 retention samples from bd inventory were evaluated by functional draw testing and no issues were observed relating to air bubbles as all samples met specifications.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode air bubbles.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends h3 other text : see h10.
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Event Description
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It was reported that during use with bd vacutainer® safety-lok¿ blood collection set with pre-attached holder air bubbles formed and blew patient's vein.There was no additional impact reported.The following information was provided by the initial reporter: customer reports cat # 368652 had started drawing air with the blood, going super, and blew the patient's vein.
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Search Alerts/Recalls
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