MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC SAFETY PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT - 20 FR - PULL; DH EF PEG INITIAL PLACEMENT PRODUCTS

Model Number 7180-20

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Code Available (3191)

Event Date 11/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The sample is reported to be available, but has not yet been received by the manufacturer.The device history record for the reported lot number, 002978040, 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 (b)(6) 2019 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, inc.Complaint database and identified as complaint (b)(4).

Event Description

It was reported the patient went to the healthcare facility for removal of a peg tube that couldn¿t be removed in the clinicians office.We will save tube and also i will send information.Additional information received 03-dec-2019 stated the device was placed in the patient at the 2cm marking.The device was placed on (b)(6) 2019.The patient experienced abdominal pain during the attempted removal by traction.Since the device was unable to be removed by standard traction per protocol, it had to be removed by egd (esophagogastroduodenoscopy) as a foreign body.

Manufacturer Narrative

One used sample device was returned.No product packaging was received with sample device.The product did not contain a lot number.The device was evaluated and the failure was not confirmed.The root cause was not identified.All information reasonably known as of 26-feb-2020 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 product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 17-jan-2020 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 SAFETY PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT - 20 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: 9511931
• MDR Text Key: 190764509
• Report Number: 3006646024-2019-00034
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10680651409796
• UDI-Public: 10680651409796
• 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,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: 7180-20
• Device Catalogue Number: 104097902
• Device Lot Number: 002978040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 12/23/2019; 02/03/2020
• Supplement Dates FDA Received: 01/19/2020; 02/27/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly
• Patient Age: 79 YR
• Patient Weight: 48