MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO PEG KIT WITH ENFIT CONNECTOR - PULL METHOD; DH CPK PEG INITIAL PLACEMENT PRODUCTS

Model Number 50-6016E1

Device Problems Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problems Abdominal Pain (1685); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/05/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The actual complaint product was not returned for evaluation.Root cause could not be determined.The device history record for lot 30044413 was reviewed and the product was produced according to product specifications.All information reasonably known as of 16 jul 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.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).

Event Description

It was reported that the patient began complaining of pain upon flushing the peg tube.A cttap (computed tomography of thorax, abdomen and pelvis) was performed and indicated free gas was present in the abdomen.It also indicated that the peg tube was not "connected to the stomach." details of the peg placement procedure were provided.The endoscopy to place the peg tube occurred on (b)(6) 2021.The tube was placed due to the patient's oesophageal tumour, as the patient was not tolerating the ng (nasogastric) tube, and was unable to swallow.During the endoscopy, erosive gastritis was noted in the stomach.Four oesophageal biopsies were also taken during the placement procedure.Patient tolerated mild discomfort during placement but became agitated during the biopsies.The patient was given fentanyl (50 micrograms) midazolam (2mg) oxygen prn for sedation, flucloxacillin 1.0 iv was administered before the procedure, and 5ml of 1% lignocaine given at the planned stoma site.The peg was "fixed at 3.5cm" and placement was noted as "successful." per additional information received 7 jul 2021, the peg tube was lying anterior to the stomach, about 1.8cm away from the skin within the peritoneal cavity with locules of gas surrounding the tip of the peg.No communication with the stomach was identified.Additional information has been requested.

Manufacturer Narrative

All information reasonably known as of 10 aug 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.

Event Description

Per additional information received 03 aug 2021 from the nutrition nurse, the assumption was that the peg was dislodged and migrated, it did not break, and it remains in the patient's abdominal wall at this time.A ct scan was performed at some point after the procedure and revealed that the peg was not connected with the lumen of gastrointestinal tract it was dislodged from its original site.The nutrition nurse feels that the peg may have been pulled out, by patient or other.There was no confirmation of the initial correct placement of the peg via x-ray or other scan, "as normally it is not necessary from clinical point of view." however, she does confirm that there was nothing indicating that it was not placed correctly.Additional information included that no sutures were used, as that is not their normal protocol for peg placement.The patient was discharged home on (b)(6) 2021 from the rehabilitation center and is eating and drinking.The decision was made to not remove the peg or place a new one based on the patient's comorbidities and fragile condition, and that the peg tube was not to be used.

• Brand Name: CORFLO PEG KIT WITH ENFIT CONNECTOR - PULL METHOD
• Type of Device: DH CPK PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12192747
• MDR Text Key: 262418707
• Report Number: 3006646024-2021-00013
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770446035
• UDI-Public: 00350770446035
• Combination Product (y/n): N
• PMA/PMN Number: K882867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 50-6016E1
• Device Catalogue Number: N/A
• Device Lot Number: 30044413
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/01/2021
• Initial Date FDA Received: 07/19/2021
• Supplement Dates Manufacturer Received: 08/03/2021
• Supplement Dates FDA Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other