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

Catalog Number	DYNJ62085C
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that medline pacemaker pack opened for procedure on (b)(6) 2024 contained contaminated raytec x-ray 4x4s.
Additional Manufacturer Narrative
The account reported finding contaminated raytec x-ray 4x4s in a pacemaker pack opened for procedure, and the product never reached patient.A photo was received for investigation; the photo shows the gauze, no other pack contents can be seen, and the first photo shows a tan/brown particulate on top of it, while the second photo shows the same particulate on the gauze and staining from the particulate on the second piece of gauze.Medline reviewed finished good production records and finished good pack build, and no non-conformances or pack build issues were noted that would have contributed to the reported issue.Based on the complaint details, photo evaluation and investigation, medline confirmed the reported issue; unfortunately, based on the information in this complaint, a true root cause could not be determined as the original source of the particulate cannot be identified, and the quality team 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-PACEMAKER PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kurian jokutty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50667397
• Report Number: 1417592-2026-33551
• Device Sequence Number: 10158592
• Product Code: OEZ
• UDI-Device Identifier: 40195327476541
• UDI-Public: 40195327476541
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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: DYNJ62085C
• Device Lot Number: 24DMH024
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 09/08/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown