MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GAUZE,SPONGE,4"X4",16PLY,XRAY,STRL,LF

Catalog Number	NON21430LF
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that they have been receiving packs of non21430lf gauze sponges in the same lot number 6052208044 and case and the ends are frayed.
Additional Manufacturer Narrative
Customer emailed stating they have been receiving packs of non21430lf gauze sponges and the ends are frayed and they are unable to use like this due to serious adverse reactions if any pieces are left behind.At this time, the correct sample has not been received for this complaint; rather than sending non21430lf, 2 bottles of dvy5019317 were sent, and without a physical sample or picture, it could not be established that the root cause was directly related to the manufacture of the product.At this time we cannot confirm a quality issue with the product based off the information received, and the cause was documented as sample required to determine cause.The divisional quality representative will continue to monitor this issue for tracking and trending purposes during quarterly trending.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,SPONGE,4"X4",16PLY,XRAY,STRL,LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nitish sandadi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50867126
• Report Number: 1417592-2026-48538
• Device Sequence Number: 21518372
• Product Code: GDY
• UDI-Device Identifier: 40080196832348
• UDI-Public: 40080196832348
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/22/2026

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: NON21430LF
• Device Lot Number: 6052208044
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/11/2023
• 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: 04/04/2023
• Initial Report FDA Received Date: 09/23/2026
• 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