Catalog Number 367364 |
Device Problems
Product Quality Problem (1506); Difficult or Delayed Activation (2577)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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D.2 medical device type: jka, fpa.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 while using bd vacutainer® ultratouch¿ push button blood collection set that there was tubing separation or kink, and shield activation issue.The following information was provided by the initial reporter: this report is about tubing failure and needle retraction before use.The customer reported that the tubing was kinked.The needle had already been retracted before use.
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Event Description
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It was reported that while using bd vacutainer® ultratouch¿ push button blood collection set that there was tubing separation or kink, and shield activation issue.The following information was provided by the initial reporter: this report is about tubing failure and needle retraction before use.The customer reported that the tubing was kinked.The needle had already been retracted before use.
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Manufacturer Narrative
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H.6.Investigation summary: bd received 3 samples and 7 photos for investigation.The photos were reviewed and the customer¿s indicated failure modes for kinked tubing and preactivation was observed.The customer samples were evaluated by visual examination and the indicated failure modes for kinked tubing and preactivation with the incident lot were observed.Additionally, 30 retention samples from bd inventory were evaluated by visual examination and the issues of kinked tubing and preactivation were not observed.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 has been confirmed for the indicated failure modes kinked tubing and preactivation.Bd was not able to identify a root cause for the indicated failure mode.The following fields were updated due to additional information: d9: device available for evaluation: yes d9: returned to manufacturer on: 2023-08-14.
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Search Alerts/Recalls
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