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

Catalog Number	DYNJ63045B
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "pouch was open when the customer opened the case of packs.".
Additional Manufacturer Narrative
The account reported finding opened breather pouch.A photo and a sample were received for investigation; medline received one unopened pack, observed no visual damage to the pack, and observed one corner of the tyvek was lifted, exposing the wrapped kit inside.The reported issue was confirmed, and medline stated that the item is received pre-sealed from the component supplier and the root cause is related to an error in the component manufacturing process.This complaint was provided to the vendor for further evaluation, and the vendor stated that there is a low probability that the lack of seal or poor sealing on one side of the bag is generated by the manufacturing process, however pneumatic cylinders revision will be included in the maintenance plan for the involved machine as part of a preventive action.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-HAND CUSTOM PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranay abbu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50867002
• Report Number: 1417592-2026-48517
• Device Sequence Number: 15781484
• Product Code: OJH
• UDI-Device Identifier: 40193489912570
• UDI-Public: 40193489912570
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 09/22/2026

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: DYNJ63045B
• Device Lot Number: 22KMA526
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/14/2023
• 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: 02/06/2023
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (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