Model Number IPN000257 |
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 02/13/2022 |
Event Type
malfunction
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Event Description
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It was reported that the balloon ruptured.As a result, the balloon was removed.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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Qn# (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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Manufacturer Narrative
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Qn# (b)(4).The product was not returned for investigation.The reported complaint of iab blood in helium pathway is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.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 the balloon ruptured.As a result, the balloon was removed.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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