MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT WITH ENFIT CONNECTORS 14 FR,PULL; DH EF PEG INITIAL PLACEMENT PRODUCTS

Model Number 8160-14

Device Problem Migration (4003)

Patient Problems Peritonitis (2252); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/29/2021

Event Type  Injury  

Manufacturer Narrative

Health effect - clinical code (appropriate health impact term/code not available): clinical decompensation.Pneumoperitoneum.The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 30-apr-2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).

Event Description

It was reported the " patient underwent peg on (b)(6) 2021.Had clinical decompensation on (b)(6) 2021.With x-ray showing pneumoperitoneum.Went to operating room where the bumper was found in the wall and formula contaminated the peritoneum." the child developed peritonitis and was still critically ill in the icu [intensive care unit].The patient has a ventriculoperitoneal shunt that was externalized due to concern for infection.The patient has abdominal abscesses that have had to be drained.The patient has had 3 additional surgical procedures.Additional information received 27-apr-2021 via medwatch 5100693 noted the above event.

Manufacturer Narrative

A review of the device history record is in-progress.All information reasonably known as of 25-may-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, 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.

Manufacturer Narrative

The device history record for the reported lot number, 30062781, 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-jun-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, 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 Description

Additional information received 02-sep-2021 stating follow-up with the physician noted the common cause in the case was that no pexy was done.The gastroenterologist works with a general surgeon on the procedure to perform the endoscopy and stoma creation/peg placement respectively; and importantly that pexies have never been part of our procedure.The patient was medically complicated with underlying health issues, cardiac, etc.The stoma came apart around 3-days post-operatively.The external disc never slipped but the physician felt the internal bumper was 'too floppy.' the patient had 'significant colonic stool burden' the clinicians thought perhaps peristalsis could have 'pulled the stomach so that it slipped off over the bumper.'.

Manufacturer Narrative

Additional information: b5 all information reasonably known as of 23-sep-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, 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 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT WITH ENFIT CONNECTORS 14 FR,PULL
• Type of Device: DH EF PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11757521
• MDR Text Key: 251455422
• Report Number: 3006646024-2021-00005
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770446110
• UDI-Public: 00350770446110
• Combination Product (y/n): N
• PMA/PMN Number: K924065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 8160-14
• Device Catalogue Number: N/A
• Device Lot Number: 30062781
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/07/2021
• Initial Date FDA Received: 04/30/2021
• Supplement Dates Manufacturer Received: 04/27/2021; 06/02/2021; 09/02/2021
• Supplement Dates FDA Received: 05/26/2021; 06/17/2021; 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 9 YR
• Patient Weight: 13