Catalog Number 682245 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 12/23/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Device evaluation: a sample was returned for evaluation but is pending evaluation.A review of the device history record revealed no abnormalities during the manufacture of the reported lot number 6168238.A supplemental mdr will be filed upon completion of the investigation.
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Event Description
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It was reported that the nurse removed the dressing from the suspect device and found the hub had detached from the cannula.The cannula remained in the patient.The patient required vascular surgery to remove the retained device.
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Manufacturer Narrative
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Device evaluation: result - one used actual sample and one unused representative sample were returned for investigation.The used sample was evaluated and a broken catheter was observed.The broken catheter was potentially cut with a sharp object.The manufacturing process was reviewed.There is no process in the manufacturing facilities that could have caused this nonconformance.The manufacturing process includes an automated vision inspection machine that will reject parts not meeting lie distance requirements.A broken catheter will automatically be rejected as the lie distance will be out of specification.Therefore, this reported nonconformance could have occurred out of the manufacturing facilities.The representative sample was evaluated and no nonconformance was observed.Conclusion - bd was able to confirm the customer's indicated failure mode with the returned used sample.An absolute root cause for this incident cannot be determined.
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Search Alerts/Recalls
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