AVANOS MEDICAL INC. ON-Q PAIN RELIEF SYSTEM WITH SILVERSOAKER ANTIMICROBIAL CATHETER, 400 ML, 5 ML; KITS
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Model Number PS12506-A |
Device Problem
Break (1069)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 05/02/2022 |
Event Type
malfunction
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Event Description
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It was reported "that during the removal of the catheter the distal end of the catheter was retained in the patient."(b)(6) the clinicians removed both catheters, both catheters came out without resistance, however one of the catheters did not have the distal black tip (the other did).There are no signs of pulling on the catheter."left in situ due to patient conditions." the catheter was sutured through.
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Manufacturer Narrative
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The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is in-progress.All information reasonably known as of 17-aug-2022 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.
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Manufacturer Narrative
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The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 22-sep-2022 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.
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Manufacturer Narrative
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The device history record for the reported lot number, 30105458, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The device was evaluated.The catheter sample was observed to be broken, no black tip was observed, the defect was confirmed.The manufacturing process was reviewed and no abnormal conditions were found that could damage the catheter.The complaint disposition is confirmed.Root cause could not be determined.All information reasonably known as of 21-oct-2022 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.
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