MAUDE Adverse Event Report: COVIDIEN 6716 KERLIX RL 4.5X3.1YD 8PLY; GAUZE/SPONGE,NONRESORBABLE FOR EXTERNAL USE

Model Number	6716
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that the ortho surgeon is concerned about the integrity of the current kerlix rolls that are on supply stating that the bandages should be strong enough to tug on and not break but recently the rolls will easily break once they are tugged on.It is almost like they are dry rotted.They opened a new one with an expiration date of 20-apr-2026 and it shredded as soon as it was tugged on.Per the customer on 13-aug-2021 it is unknown how many rolls were affected, the issues occurred during patient use on an unknown number of patients during surgery.No known injuries at this time per the reporter.
Additional Manufacturer Narrative
Samples were not received for the investigation.The device history record (dhr) was reviewed and indicated that the product was released accomplishing all quality standards.The dhr review identified that the stretched and unstretched length(in) were within limits.Without samples to analyze, the reported issue could not be confirmed and an exact root cause could not be determined.Finished good testing is already in place to measure the percentage of stretch in the kerlix rolls.Results of the test are included in the device history record.No further actions are applicable at this time.If a sample is received at a later date, this complaint will be reopened for further investigation.The complaint will be used for tracking and trending purposes.

• Brand Name: 6716 KERLIX RL 4.5X3.1YD 8PLY
• Common Device Name: GAUZE/SPONGE,NONRESORBABLE FOR EXTERNAL USE
• Manufacturer (Section D): COVIDIEN; 1430 marvin griffin road, po b; augusta GA 30906
• Manufacturer (Section G): COVIDIEN; 1430 marvin griffin road, po b; augusta GA 30906
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12356764
• Report Number: 1018120-2021-00453
• Device Sequence Number: 17164206
• Product Code: NAB
• UDI-Device Identifier: 10884521058460
• UDI-Public: 10884521058460
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2021

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 Expiration Date: 04/20/2026
• Device Model Number: 6716
• Device Catalogue Number: 6716
• Device Lot Number: 21E001262
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown