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

Catalog Number	NON21430LF
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Other
Event or Problem Description
It was reported that ¿this sponge opened weird.Couldn¿t use because it was not sterile.¿.
Additional Manufacturer Narrative
The customer reported that the sponge opened weird and could not be used because it was not sterile.A single tray was provided by the customer; the tray seemed to have been opened by the customer with the seal of the tray ripped on the right side, and the seal on the tray peeled off incorrectly with a part of the seal still attached to the plastic tray.Based on the sample provided, medline confirmed the reported issue, and the cause was recorded as cannot determine cause with received sample.Medline evaluated 6 months of complaint history for this product and found no similar complaints, the vendor was notified, and 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: sangameswaran saravanakumar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50897177
• Report Number: 1417592-2026-50818
• Device Sequence Number: 10712255
• Product Code: GDY
• UDI-Device Identifier: 40080196832348
• UDI-Public: 40080196832348
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Catalogue Number: NON21430LF
• Device Lot Number: 26022120012
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/26/2023
• 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: 10/19/2023
• Initial Report FDA Received Date: 09/25/2026
• 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