Catalog Number 380073 |
Device Problem
Free or Unrestricted Flow (2945)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 01/18/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.The reported lot # 1110435 was not found for the reported catalog # 380073.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported bd¿ pro safety arterial catheter had an improperly functioning flow switch.The following information was provided by the initial reporter: "the operators complain that the flow switch valve is released and it is no longer possible to re-screw it to the luer lock, also after a few uses the valve remains completely open".
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Event Description
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It was reported bd¿ pro safety arterial catheter had an improperly functioning flow switch.The following information was provided by the initial reporter: "the operators complain that the flow switch valve is released and it is no longer possible to re-screw it to the luer lock, also after a few uses the valve remains completely open".
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Manufacturer Narrative
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The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 22-mar-2022.H6: investigation summary.A device history review was conducted for lot number 1110435.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, a sample was returned to our facility to aid in our investigation.Functional testing was performed both on the returned unit and on the available retention samples for the affected lot.The results show that the tested units performed within product specifications for both the retained and returned units.Unfortunately, without the ability to replicate the reported failure mode our quality engineers were unable to determine the root cause for this complaint.H3 other text : see h10.
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Search Alerts/Recalls
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