Model Number 98430 |
Device Problem
Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/04/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device history record for lot aa9189r03 was reviewed and the product was produced according to product specifications.All information reasonably known as of 15 jul 2020 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.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 complaint database and identified as complaint (b)(4).
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Event Description
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It was reported that all sutures came off on day 3 post placement.It was advised to delay the water change in the balloon (of associated 8110-12lv mic* bolus gastrostomy feeding tube with enfit connector) by one week, and also to add an additional 1ml water to the balloon.An additional 1 ml of water was added on (b)(6) 2020.There had also been a small amount of bleeding at the site.The bleeding had improved by the discharge date.On follow ups with the community nurse on (b)(6) 2020, leakage around the stoma site was noted.On (b)(6) 2020, a ct scan was performed on the patient at a&e which showed that the tube had become displaced.The tube was removed.No further information provided.
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Event Description
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Per additional information received on 22 jul 2020 from (b)(6), the patient's radiologically inserted gastrostomy (rig) tube had been placed on (b)(6) 2020.One of the sutures was not fixed in position on day 1 post procedure.Nursing staff was advised to monitor and take care when cleaning the rig site.Additional details provided "4cm at skin.3x sutures present, but 3rd suture hanging at end of thread.Day 2: fresh blood at rig site, position 4cm at skin.By day 3 all sutures off.Day 3: taken to interventional radiology (ir) for review of site, 2x sutures fallen off.Recommended to delay balloon water by 4 weeks.More fresh blood on ward and third suture off.".
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Manufacturer Narrative
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The device is not being returned to avanos for evaluation.No root cause could be determined.All information reasonably known as of 11 aug 2020 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 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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Search Alerts/Recalls
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