MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; STANDARD MINOR PACK

Catalog Number	DYNJ47614C
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿component 107941 pack of 10 4x4 x-ray gauze.Pack only had 9 each.¿.
Additional Manufacturer Narrative
The account reported finding miscount gauze pack; component 107941 pack of 10 4x4 x-ray gauze had 9 each.No sample or photo was received for the investigation; finished good production records, the bill of materials (bom), and packaging instructions were reviewed, and there were no line-down situations, no run without approvals, deviations or non-conformance reports, and no change to the bom or placement of components that would have contributed to the reported defect.At this time, medline was unable to confirm the reported defect, as no physical sample or detailed photographic evidence was provided; the cause was documented as ¿sample required to determine cause¿ and ¿unconfirmed defect.¿ the division will monitor this issue for trending purposes, and a risk assessment was completed with the incident found to be acceptable.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: STANDARD MINOR PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: ankitha komirishetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50223614
• Report Number: 1417592-2026-15996
• Device Sequence Number: 5445481
• Product Code: FDE
• UDI-Device Identifier: 10198459204128
• UDI-Public: 10198459204128
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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

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: DYNJ47614C
• Device Lot Number: 25GBH916
• Was Device Available for Evaluation?: Yes
• 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: Not provided
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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