Catalog Number 394600 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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 the bd connecta¿ stopcock 3-way connection was loose and separated.The following information was provided by the initial reporter: we have had incidents lately with the material reference: 394600.The lots we are aware of are 2032403c.The 3-step stopcocks do not close properly and disconnect from the patient during surgery, stopping the infusion of the medication during general anaesthesia.
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 11-jan-2023.H6: investigation summary: our quality engineer inspected the 1 sample submitted for evaluation.The reported issue of connection issues was not confirmed upon inspection of the sample.Analysis of the sample showed that there were no irregularities or damages on the connector.The connector was tested and there were no issues with the connection of the sample.Bd could not determine a manufacturing related root cause since the failure was not confirmed by the sample evaluation.The device history records (dhr) review was performed for the lot number material identified in this complaint.According to the documented records, the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.
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Event Description
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It was reported that the bd connecta¿ stopcock 3-way connection was loose and separated.The following information was provided by the initial reporter: we have had incidents lately with the material reference: (b)(4).The lots we are aware of are 2032403c.The 3-step stopcocks do not close properly and disconnect from the patient during surgery, stopping the infusion of the medication during general anaesthesia.
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Search Alerts/Recalls
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