MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-EXTREMITY PACK

Catalog Number	DYNJ60482B
Medical Device Problem Codes	Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "there are holes and tears in the sealed parts of the packaging and all the items in the cases have been compromised.".
Additional Manufacturer Narrative
The customer stated there were holes and tears in the sealed part of the packaging and all the items in the cases have been compromised.Photo and a sample were received for the investigation; medline received 2 photos and a physical sample for 8 opened packs, observed the clear seals were opened and partially opened on some of the packs, and found no signs of damage to the breather pouch.Finished good production records and finished good pack build were reviewed, and the investigation confirmed the packs were partially sealed with signs of inconsistent sealing marks on the breather pouch.The root cause of human/manual assembly error was determined based on no seal evidence present on the physical sample, indicating the pouch was not placed properly in the machine, which resulted in the seal not being applied as intended; production and qc managers were notified, feedback was provided to the build team, and medline will monitor this issue for trending purposes.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: DBD-EXTREMITY PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: maya mcknight ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50691493
• Report Number: 1417592-2026-34710
• Device Sequence Number: 12244058
• Product Code: OJH
• UDI-Device Identifier: 40193489235488
• UDI-Public: 40193489235488
• 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
• Report Date (Section B): 09/04/2026

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: DYNJ60482B
• Device Lot Number: 23JBX884
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/23/2024
• 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: 01/17/2024
• Initial Report FDA Received Date: 09/09/2026
• 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