Model Number 366594 |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/05/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.(b)(4).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 when using the bd microtainer® contact-activated lancet there was a retraction issue, delay or no retraction.The following information was provided by the initial reporter.The customer stated: "the blade of the lancet did not come out upon venipuncture.".
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Manufacturer Narrative
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The following fields have been updated with additional information: d9: device available for evaluation: yes.D9: returned to manufacturer on: 2022-09-19.Bd received 1 sample and 4 photos for investigation.The photos were reviewed and the indicated failure mode for unable to activate with the incident lot was not observed.Additionally, the customer sample along with retention samples from bd inventory, were evaluated by visual examination and functional testing and no issues were observed relating to unable to activate 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 activate.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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Event Description
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It was reported when using the bd microtainer® contact-activated lancet there was a retraction issue - delay or no retraction.The following information was provided by the initial reporter.The customer stated: "the blade of the lancet did not come out upon venipuncture.".
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Search Alerts/Recalls
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