Model Number 8270-16-7.0-45 |
Device Problems
Complete Blockage (1094); Fluid/Blood Leak (1250)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/08/2021 |
Event Type
malfunction
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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.The device history record for lot 20006182 was reviewed and the product was produced according to product specifications.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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Event Description
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It was reported that the jejunostomy tube split around the gastric portion, resulting in feed leaking into the patient's stomach.No injury to the patient.No further information provided.
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Event Description
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Per additional information received 4 feb 2021, the device had been in use for 73 days.The patient went to a&e after noticing gastric contents leaking through the jejunostomy feeding port.The distributor reports that the tube was also occluded.
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Manufacturer Narrative
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All information reasonably known as of 19 feb 2021 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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Manufacturer Narrative
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One used sample was returned for evaluation.During initial examination, a whitish brownish foreign material appeared to be stuck inside the jejunal lumen.During the decontamination process, most of this build up was flushed away.Feeding was simulated through the jujunal port and leakage was observed in the gastric skives area.Feeding was simulated through the gastric port and leakage was observed into the jujunal lumen.The gastric skives were examined under magnification.The inner wall of the tubing which separates the jejunal and gastric lumens had torn approximately 6mm which allowed for an inner lumen crossover.The tearing effect appeared slightly jagged.The complaint was confirmed as reported, however, no root cause could be determined.Obstructions are usually caused by formula/feed accumulation inside the tube.No manufacturing related issued were identified during the investigation.All information reasonably known as of 16 mar 2021 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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