Model Number 119208M |
Device Problems
Device Sensing Problem (2917); Component Misassembled (4004)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
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Event Description
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It was reported that temperature-sensing catheter were defective.As per the follow up via email on 11 sep 2020, according to the report, two catheters were used on the patient.No negative impact noted other than multiple unnecessary catheterizations.The exact defect in the catheter was not flushed.
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Manufacturer Narrative
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The reported event was confirmed as manufacturing-related.Visual inspection noted one temperature sensing catheter was received.Visual evaluation noted the thermistor wire was not sitting properly in the thermistor lumen.The drainage lumen was flushed to find that the solution sat in the funnel just above the trifurcation.The catheter was dissected below the trifurcation to find that the thermistor wire had cut through the thermistor wire/drainage lumen wall and was inside the drainage lumen completely blocking the flow of the solution.This fails to meet specifications stating "cuts in lumens are not allowed".Although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure could be tooling misalignment.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not performed because labeling could not have prevented the reported failure.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that temperature-sensing catheter were defective.As per the follow up via email on 11sep2020, according to the report, two catheters were used on the patient.No negative impact noted other than multiple unnecessary catheterizations.The exact defect in the catheter was not flushed.
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Search Alerts/Recalls
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