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

Catalog Number	DYNJ61294D
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that spt-4124 drape transradial 86 x 148 has been difficult to unfold and is sticking to itself.
Additional Manufacturer Narrative
The account reported finding drape issues; spt-4124 drape transradial 86 x 148 has been difficult to unfold and is sticking to itself.No sample or photo was received for the investigation; finished good production records were reviewed and no non-conformances were noted that would have contributed to the reported issue, and finished good pack build was reviewed with no issues that might have an impact on the issue.The defect was not able to be confirmed as there were no samples or detailed pictures received, and without a sample it is difficult to determine a true root cause for the reported issue.The supplier quality team will monitor this issue for trending purposes, and if a sample, photo, and/or additional information becomes available, the complaint will be reopened to be further investigated.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-HEART CATH PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azmat shah ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50693779
• Report Number: 1417592-2026-34950
• Device Sequence Number: 15866782
• Product Code: OEZ
• UDI-Device Identifier: 40193489305402
• UDI-Public: 40193489305402
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/09/2026

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: DYNJ61294D
• Device Lot Number: 23HBC090
• Was Device Available for Evaluation?: No
• 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: 10/19/2023
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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