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

Model Number 8170-20

Device Problem Unintended Movement (3026)

Patient Problems Death (1802); Peritonitis (2252)

Event Type  Death  

Manufacturer Narrative

The actual complaint product was not returned for evaluation; unused/sealed samples were returned.A review of the device history record is in-progress.All information reasonably known as of 28-jun-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.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.(b)(4).The actual device was not returned.

Event Description

It was reported the physician observed the outer bumper of the peg tube was "sliding" on the tube.Additional information received 31-may-2019 stated the patient had been diagnosed with cancer.Additional information received 05-jun-2019 stated the patient died at an unknown date.The physician felt the issue with peg the tube caused the development of peritonitis and contributed to the patient's death.

Event Description

Additional information received 30-aug-2019 stated the physician stated he, does "a lot" of these, all with the same devices.He never places pexy sutures (relies on peg lock).He has never had an issue like this.He "only did one case that day, so kit components could not have been mixed from another device type/size.He placed the peg [and] never thought too much about it, but in retrospect it may have felt a bit loose." the next day his patient complained of abdominal pain, [and] on examination the peg lock was loose.The physician "thought it may have become disturbed by the patient¿s movement"; so he re-seated it [and] tried to hold it with a suture tie, but that never worked.He wonders if "the rubber was too slippery in this case.".

Manufacturer Narrative

The device history record for the reported lot number, 0203131287, 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 19-sep-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.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 WITH ENFIT CONNECTORS
• Type of Device: DH EF PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8746671
• MDR Text Key: 149627507
• Report Number: 3006646024-2019-00011
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 30680651446009
• UDI-Public: 30680651446009
• Combination Product (y/n): N
• PMA/PMN Number: K924065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2020
• Device Model Number: 8170-20
• Device Catalogue Number: 104460000
• Device Lot Number: 0203131287
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Death