COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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Model Number 8813817009 |
Device Problem
Hole In Material (1293)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/14/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during procedure before the insertion of the catheter, it was noticed that there was a leak from the arterial line of the catheter's silicone extension when checked with heparinized saline.A new catheter was used for the insertion.There was no patient injury.
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Manufacturer Narrative
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Evaluation summary: a device history review (dhr) revealed no discrepancies that may have contributed to a complaint of this failure mode.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements.In addition, all dhr are reviewed for accuracy prior to product release.The actual sample involved in the reported incident was not returned for evaluation.No additional information, pictures or videos were received.Consequently, it was not possible to evaluate it as part of a comprehensive failure investigation.No probable cause was found since no sample, picture or video were received for testing, therefore the defect is not confirmed.If the sample is returned in the future, this complaint will be re-opened for further investigation.No trends or triggers have been found.No action is deemed necessary at this time.It must be noted that in-process controls are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during the procedure before the insertion of the catheter, it was noticed that there was a leak from the arterial line of the catheter's silicone extension when checked with heparinized saline.A new catheter was used for the insertion and the procedure was completed.There was no reported patient injury.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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