MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-PERMANENT PACING

Catalog Number	DYNJ44886N
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we are having issues with the pacer drapes in our pacemaker packs" and "i have had several of our staff members saying that they are not sticking.Fluid runs out, and they are pulling up which is also causing heat from our bear hugger to get up to the pocket.".
Additional Manufacturer Narrative
It was reported that pacer drapes are not sticking.Fluid runs out, and they are pulling up which is also causing heat from our bear hugger to get up to the pocket.Extra towels are being placed as a barrier and to help reduce the chance of contamination.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-PERMANENT PACING
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: juan mota ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50196200
• Report Number: 1417592-2026-14964
• Device Sequence Number: 21311139
• Product Code: LRO
• UDI-Device Identifier: 10195327644680
• UDI-Public: 10195327644680
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 08/10/2026

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: DYNJ44886N
• Device Lot Number: 24HBJ970
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/17/2025
• 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: 02/12/2025
• Initial Report FDA Received Date: 08/10/2026
• 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