AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 24FR DILATOR; DH EF PERC PLACEMENT PRODUCTS
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Model Number 98434 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 08/06/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The actual complaint product was not returned for evaluation.Root cause could not be determined.The device history record for lot 30027185 was reviewed and the product was produced according to product specifications.All information reasonably known as of 25 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).
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Event Description
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It was reported that during the procedure, the dilator broke.The broken piece was retrieved from the patient using jaw forceps, and there was no injury to the patient.Per additional information received 7 aug 2020, the distal end of the dilator had broken, leaving a 1.5 inch section in the patient.The procedure was able to be completed with the broken dilator.No further information provided.
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Search Alerts/Recalls
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