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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC STANDARD PEG KIT - PULL METHOD; DH EF PEG INITIAL PLACEMENT PRODUCTS
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AVANOS MEDICAL INC. MIC STANDARD PEG KIT - PULL METHOD; DH EF PEG INITIAL PLACEMENT PRODUCTS Back to Search Results
Model Number 9640-20
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Perforation of Esophagus (2399)
Event Date 12/02/2021
Event Type  Injury  
Event Description
The customer reported that the mic peg was put in place on (b)(6) 2019; it had been in place for a long time and it was unable to be pulled for removal and had to be removed via gastroscope on (b)(6) 2021.Per additional information received on (b)(6) 2021; during the gastroscopy removal the peg tube was cut and removed, and when passing the mic peg up the esophagus it perforated the esophagus.The patient was admitted into the surgical department with damage to the esophagus; the patient¿s condition is unknown.
 
Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.All information reasonably known as of on (b)(6) 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).
 
Event Description
The customer reported that the mic peg was put in place on (b)(6) 2019; it had been in place for a long time and it was unable to be pulled for removal and had to be removed via gastroscope on (b)(6) 2021.Per additional information received on (b)(6) 2021; during the gastroscopy removal the peg tube was cut and removed, and when passing the mic peg up the esophagus it perforated the esophagus.The patient was admitted into the surgical department with damage to the esophagus; the patient¿s condition is unknown.
 
Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.All information reasonably known as of on (b)(6) 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).
 
Manufacturer Narrative
The device history record for lot 9640-20 was reviewed and the product was produced according to product specifications.The actual sample from the reported event was returned for evaluation.Visual examination of the device revealed the bumper component to be hardened.Evaluation of the sample revealed no excessive or unusual flashing around the bumper, additionally there were no breakages, cracking or tearing on the bumper.The reported event could not be confirmed as reported.The root cause is undetermined at this time.The peg kit in this complaint included an ifu (instructions for use) for mic percutaneous endoscopic gastrostomy (peg) kit with enfit connectors.The indications for use in the ifu state that the device is intended as an initial placement device.The ifu also states that the peg tube may be replaced with an alternative feeding device such as a mic-key low-profile gastrostomy tube or a mic gastrostomy tube when the physician determines that the tract is formed (usually within 4¿6 weeks after placement of peg).The daily care & maintenance check list in the ifu instructs to assess the tube for any abnormalities such as damage, clogging, or abnormal discoloration.All information reasonably known as of 26jan2022 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.Database and identified as complaint (b)(4).This information is submitted 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.
 
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Brand Name
MIC STANDARD PEG KIT - PULL METHOD
Type of Device
DH EF PEG INITIAL PLACEMENT PRODUCTS
Manufacturer (Section D)
AVANOS MEDICAL INC.
5405 windward parkway
alpharetta GA 30004
Manufacturer (Section G)
AVENT, INC.
6620 s. memorial place, suite 100
tucson 85756
Manufacturer Contact
lisa clark
5405 windward parkway
alpharetta, GA 30004
4704485444
MDR Report Key13026032
MDR Text Key285624258
Report Number3006646024-2021-00024
Device Sequence Number1
Product Code KNT
UDI-Device Identifier00350770446431
UDI-Public00350770446431
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K924065
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/31/2020
Device Model Number9640-20
Device Catalogue NumberN/A
Device Lot Number0203076379
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2021
Was the Report Sent to FDA? No
Date Manufacturer Received01/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/26/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age80 YR
Patient SexFemale
Patient Weight70 KG
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