MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; PTCA KIT

Catalog Number	DYNJ40025B
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Holdlp10.It was reported that the drapes are very "sticky" and seem like the drapes are extremely stuck together as if it has been vacuum sealed.The issue comes when the nurse is draping the patient; having to unfold the drape when it is so stuck together has led to issue with sterility.
Additional Manufacturer Narrative
Holdlp10.It was reported that ¿the drapes are very "sticky" and seem like the drapes are extremely stuck together as if it has been vacuum sealed.The issue comes when the nurse is draping the patient; having to unfold the drape when it is so stuck together has led to issue with sterility.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: PTCA KIT
• 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: 50195554
• Report Number: 1417592-2026-14898
• Device Sequence Number: 6111119
• Product Code: OJH
• UDI-Device Identifier: 10889942896455
• UDI-Public: 10889942896455
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: DYNJ40025B
• Device Lot Number: 25GBK241
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/25/2025
• 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: 10/02/2025
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (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