MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC PEG KIT WITH ENFIT CONNECTORS - 20 FR - PULL; DH EF PEG INITIAL PLACEMENT PRODUCTS

Model Number	9640-20
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the initial peg (percutaneous endoscopic gastrostomy) tube was cut and retrieved."the gastro[enterologist] said it was very difficult to retrieve as the bumper did not collapse and there was difficulty removing it out of the esophagus." the device was retrieved via endoscopy.The peg tube was placed on (b)(6) 2022.
Additional Manufacturer Narrative
The actual sample from the reported event was returned for evaluation.The device history record for the reported lot number, 30157319, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 17-apr-2024 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.
Additional Manufacturer Narrative
All information reasonably known as of 24-may-2024 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.
Event or Problem Description
Additional information received 29-apr-2024 stating, "no injuries.Patient complained of sore throat for 2-weeks after tube pulled out through the esophagus ¿ difficult removal of bumper due to bumper not collapsing.".
Additional Manufacturer Narrative
The device history record for the reported lot number, 30157319, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The sample was received without the original packaging.No information regarding lot number was received.Upon receipt of the device, an obvious separation of bumper from the entirety of tubing was seen.The returned device appeared very dirty with the bumper component color was darkish brown.The other portion of tubing had a mixture of dark brownish-blackish colors in the interior and exterior with some build-ups that cannot be removed or flushed through.This tube was where the clamp and secur-lok were placed.Approximately, 1.5 inches of tubing towards the bumper was cut off (on the 3cm mark).This was the other part of the cut tubing.There were no visible damages observed on the bumper component (top and under) when viewed under magnification.No dried, blister-like appearance was present.Since the tubing was identified to be "cut and retrieved", the cut area appeared fairly smooth but slanting.Root cause could not be determined.All information reasonably known as of 17-jun-2024 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.

• Brand Name: MIC PEG KIT WITH ENFIT CONNECTORS - 20 FR - PULL
• Common Device Name: DH EF PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT, INC.; 6620 s. memorial place, suite 100; tucson AZ 85756
• Manufacturer Contact: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 19138805
• Report Number: 3006646024-2024-00012
• Device Sequence Number: 18484966
• Product Code: KNT
• UDI-Device Identifier: 00350770446431
• UDI-Public: (01)00350770446431(11)211116(17)231005(10)30157319
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K924065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2024

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: 10/05/2023
• Device Model Number: 9640-20
• Device Catalogue Number: N/A
• Device Lot Number: 30157319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 04/29/2024; 06/02/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 05/24/2024; 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 70 KG