Model Number IPN000260 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/18/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).There is an investigation ongoing into this reported complaint.A supplement follow-up mdr report will be submitted with the investigation results upon completion of the investigation.
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Event Description
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It was reported that blood was found in the pressure tubing extension.As a result, the catheter was withdrawn and re-punctured to replace with a new catheter.Therapy was continued successfully after the replacement.
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Manufacturer Narrative
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Qn#(b)(4).Teleflex received the device for investigation.The reported complaint of iab blood in helium pathway is confirmed.During the investigation, the iabc central lumen was noted broken near the iabc distal tip, which caused blood to enter the helium pathway.The iabc bladder membrane was fully intact, with no leaks noted.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.
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Event Description
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It was reported that blood was found in the pressure tubing extension.As a result, the catheter was withdrawn and re-punctured to replace with a new catheter.Therapy was continued successfully after the replacement.
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Search Alerts/Recalls
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