EDWARDS LIFESCIENCES, PR SWAN-GANZ TRUE SIZE MONITORING CATHETER DOUBLE LUMEN; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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Model Number 123F6P |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/09/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device evaluations are anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation results when received.A device history record review was completed and documented that device met all specifications upon distribution.H3 other text : devices not returned.
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Event Description
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It was reported that prior to use, the packaging on these 5 swan-ganz catheters from the same lot number were observed to have puncture-like holes and what looks like condensation marks.Images were provided by the customer.There was no patient injury reported.The customer shared that there were multiple devices that had the same issue.As a result of the issue found, the customer pulled their model 123f6p and 110f5 swan-ganz catheters and inspected them all for holes in the packaging.The issue was resolved by switching to a non-edwards brand pulmonary artery catheter.
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Manufacturer Narrative
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Five 123f6 catheters, in sealed packaging, were returned for examination.The reported issue of "marks" was confirmed.As received, indentations and opaque marks around the indentations were observed on the outer surface of the plastic tray.The marks were part of the tray and were not condensation.Most indentations were 0.03" in diameter.The marks were round and varied in sizes.The images provided by the customer had similar marks as the received product.The report of "puncture holes" was not confirmed.The indentations did not penetrate the tray.There was no other visible defect or damage observed from the packaging.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
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Search Alerts/Recalls
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