MAUDE Adverse Event Report: AVENT SA DE R.L. DE C.V. (AVENT 1) MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT WITH ENFIT CONNECTORS - 20 FR -; DH EF PEG INITIAL PLACEMENT PRODUCTS

Model Number	8150-20
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: the initial medwatch report was submitted using, 2026095-2022-00068; new information received on 08aug2022 reported the manufacturing site as 9611594-2022-00115.All future mw(s) for this report will be submitted using 9611594-2022-00115; no further information will be submitted under: 2026095-2022-00068.The product involved in the report has been returned and is being processed for evaluation.The device history record for lot 30171330 was reviewed and the product was produced according to product specifications.All information reasonably known as of 07 sep 2022 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.
Event or Problem Description
Avanos medical inc.Received a single report that referenced two different incidences, which were associated with separate units, involving two different units.This is the second of two reports.Refer to 2026095-2022-00068 for the first report.It was reported that the gastrointestinal (gi) physician was unable to remove the tube from the patient as per normal procedure and had to cut the tube; there was no reported injury.Additional information received 30jun2022 reported that the tube was placed on (b)(6) 2022; there was no reported injury additional information received 01jul2022 reported the tube was in place for 6 weeks and confirmed there was no patient injury.Additional information received 18jul2022 the tube was removed endoscopically; there was no reported injury.
Additional Manufacturer Narrative
The actual sample from the reported event was returned for evaluation.Visual examination of the device revealed: the sample tube appeared cut between 6 and 4cm marking and there were no obvious defects seen on the bumper component area.Inspection of the bumper under magnification (20x) revealed, there was no excessive material build-up around the bumper's top, bottom and side portions.The bumper was felt with gloved fingers: no burrs or jagged edges felt at the surface and there was no obvious biological matter(s) found on the outer portion of the tubing and bumper (prior to decontamination); no obvious defects were identified on the device.The cause of the issue appeared to be lack of lubricant on the skin and tube around the stoma with the water-soluble lubricant; the root cause is user: incorrect use.All information reasonably known as of 04 oct 2022 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.
Event or Problem Description
The report was initially received on 23jun2022.

• Brand Name: MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT WITH ENFIT CONNECTORS - 20 FR -
• Common Device Name: DH EF PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V. (AVENT 1); circuito industial no.40; colonia obrera; nogales, cp
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 15372662
• Report Number: 9611594-2022-00115
• Device Sequence Number: 6324286
• Product Code: BSY
• UDI-Device Identifier: 00350770446165
• UDI-Public: 00350770446165
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2022

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: 03/31/2023
• Device Model Number: 8150-20
• Device Catalogue Number: N/A
• Device Lot Number: 30171330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown