Catalog Number 367336 |
Device Problem
Difficult or Delayed Activation (2577)
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Patient Problem
Discomfort (2330)
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Event Date 07/31/2023 |
Event Type
malfunction
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Manufacturer Narrative
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There were multiple medical device types reported to be involved.The information for the additional device type is as follows: d.1 medical device type: fpa.D.2.Common device name: intravascular administration set.H.3.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 during use with bd vacutainer® push button blood collection set it was difficult to activate the safety feature.This is 2nd of 2 reports.The following information was provided by the initial reporter, translated from french to english: during blood sampling, the nurse encounters difficulties with the safety of the device when retracting the needle.They were resistant on 2 samplings.Patient or user impact: patient's vein injured, resulting in an effusion.
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Event Description
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It was reported that during use with bd vacutainer® push button blood collection set it was difficult to activate the safety feature.This is 2 of 2 reports.The following information was provided by the initial reporter, translated from french to english: during blood sampling, the nurse encounters difficulties with the safety of the device when retracting the needle.They were resistant on 2 samplings.Patient or user impact: patient's vein injured, resulting in an effusion.
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Manufacturer Narrative
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H.6 investigation summary: bd had not received samples or photos for investigation.Therefore, 10 retention samples from bd inventory were evaluated by functional testing, each of their safety features being activated, and no issues were observed relating to unable to retract 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 unable to retract.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 h.10.
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Search Alerts/Recalls
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