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

Catalog Number	DYNJ60501F
Medical Device Problem Code	Adhesive Too Strong (4071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "customer is having a problem with this packs drape.Drape sticks to itself and very difficult to drape on the patient.".
Additional Manufacturer Narrative
The account reported finding adhesive issue with drape, and the drape sticks to itself and was very difficult to drape on the patient.No sample or photo was received for the investigation; finished good production records, finished good pack build, account complaint history, and component complaint history were reviewed.The reported issue was unable to be confirmed due to no sample or photo being received, and the cause was documented as sample required to determine cause.There were no line down situations that might have had an impact on this issue, no issues with the build that likely contributed to the reported issue, and division will monitor 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-ANGIOGRAPHY PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: urmi parekh ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50846350
• Report Number: 1417592-2026-46944
• Device Sequence Number: 9957735
• Product Code: OEQ
• UDI-Device Identifier: 40193489846356
• UDI-Public: 40193489846356
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 09/21/2026

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: DYNJ60501F
• Device Lot Number: 22LBG788
• 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: 02/14/2023
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown