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

Catalog Number	DYNJ55989A
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 2 of the packs came opened therefore were not usable.
Additional Manufacturer Narrative
The customer reported that 2 of the packs came opened and were not usable.A photo and a sample were received; in both, the edge seam of the pouch on the tyvek end was open along the top, middle of the bag, finished good production records and finished good pack build were reviewed, and finished good and component stock checks found no defects.Based on the complaint details, photo and sample evaluation, and investigation, medline confirmed the reported issue.The root cause was determined to be a vendor product issue relating to the component manufacturing process; the complaint was provided to the vendor for further evaluation, supplier quality will monitor this issue for trending purposes, and further risk assessment found the incident acceptable w/ justification.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: BASIC PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: vamshi thupakula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50225316
• Report Number: 1417592-2026-16119
• Device Sequence Number: 10273488
• Product Code: FTN
• UDI-Device Identifier: 40195327251452
• UDI-Public: 40195327251452
• 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): 08/12/2026

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: DYNJ55989A
• Device Lot Number: 23KBV675
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/15/2024
• 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: 01/05/2024
• Initial Report FDA Received Date: 08/12/2026
• 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