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

Catalog Number	DYNJ69439
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported failure was that the adhesive is very weak which is not keeping the packs sealed, and the account reported finding vendor seal separated.A sample was received, and review of the sample found the middle seam of the pouch on the tyvek end had an opening along the top of the bag about seven inches in length; a white line running along the seam indicated that the pouch did go through a sealing machine and was closed at some point, and no other defects were noted.The sample evaluation confirmed an opening, but with the information provided medline was not able to confirm at what point the damage occurred; the seam likely popped open sometime after kit assembly, and it is likely that the open seal occurred after the pack left the kitting facility at some point during transit or storage.Component inventory did not find any similar issues, vendor retained samples post eo sterilization had seal strength within specification, no corrective actions were implemented by the vendor, and the vendor will continue to monitor the breather pouch in subsequent production.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.
Event or Problem Description
It was reported that the adhesive is very weak which is not keeping the packs sealed.

• Brand Name: MEDLINE
• Common Device Name: DBD-EXTREMITY PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nathan bersch ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50753558
• Report Number: 1417592-2026-39096
• Device Sequence Number: 9203201
• Product Code: OJH
• UDI-Device Identifier: 40193489941488
• UDI-Public: 40193489941488
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/14/2026

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: DYNJ69439
• Device Lot Number: 23IBC203
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/26/2024
• 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: 06/18/2024
• Initial Report FDA Received Date: 09/14/2026
• 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