Catalog Number 367365 |
Device Problem
Difficult or Delayed Activation (2577)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/21/2023 |
Event Type
malfunction
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Event Description
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It was reported that while using bd vacutainer® ultratouch¿ push button blood collection set, the needle of one device does not retract when the safety button is pressed, leaving the needle exposed.No patient impact reported.
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Manufacturer Narrative
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D2a: common device name: blood specimen collection device; intravascular administration set.E.4: the initial reporter notified the fda on 12-dec-2023.Medwatch report # mw5148482 h.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that while using bd vacutainer® ultratouch¿ push button blood collection set, the needle of one device does not retract when the safety button is pressed, leaving the needle exposed.No patient impact reported.
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Manufacturer Narrative
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The following fields were updated due to additional information: d9: device available for evaluation: yes.D.9:device eval by manufacturer? yes.D9: returned to manufacturer on: 2024-january -2nd.Material #: 367365.Lot/batch #: 2293205.Bd received 2 samples for investigation.The samples were evaluated by functional retraction testing and the indicated failure mode for unable to retract needle with the incident lot was not observed as all product specifications were met.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 needle.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.
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Search Alerts/Recalls
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