MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT - 16 FR, 7.0 CM - 45 - ENFIT; DH EF BALLOON TUBES PRODUCTS

Model Number	8270-16-7.0-45
Medical Device Problem Codes	Complete Blockage (1094); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
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.

• Brand Name: MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT - 16 FR, 7.0 CM - 45 - ENFIT
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11269655
• Report Number: 9611594-2021-00017
• Device Sequence Number: 4532720
• Product Code: KNT
• UDI-Device Identifier: 00350770479736
• UDI-Public: 00350770479736
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K922667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2021
• Device Model Number: 8270-16-7.0-45
• Device Catalogue Number: N/A
• Device Lot Number: 20006182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 02/04/2021; 03/02/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 02/22/2021; 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Weight: 70