MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GAUZE,BORDER,6"X6",4"X4"PAD,STERILE

Catalog Number	MSC3266
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that they are not able to open the gauze from the paper liner.
Additional Manufacturer Narrative
The customer reported they were not able to open the gauze from the paper liner.The vendor/manufacturer reviewed dhr and batch record, inspection record, manufacturing, raw material and equipment calibration and preventive maintenance, employee training, and retain sample, and all met the specification as required; pouch inspection records, equipment inspection records, workshop temperature and humidity, operation instructions, process regulations, and machine parameters were also reviewed.The customer reported issue "unable to open" was confirmed with the received sample for investigation.The peel force of the v-shaped sealing was too heavy, caused the tearing issue; the products can¿t be used which the products have the tear issue.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: GAUZE,BORDER,6"X6",4"X4"PAD,STERILE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranay abbu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50854415
• Report Number: 1417592-2026-47505
• Device Sequence Number: 15829608
• Product Code: NAD
• UDI-Device Identifier: 40080196743064
• UDI-Public: 40080196743064
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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 Catalogue Number: MSC3266
• Device Lot Number: 75724060003
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/03/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown