MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; LEFT HEART KIT WRO-LF

Catalog Number	DYNJ41865D
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that one of the 10ml syringes came cracked at the luer site and has a hole in the side of the syringe.
Additional Manufacturer Narrative
The account reported cracked syringes; as per client, one of the 10ml syringes came cracked at the lure site and has a hole in the side of the syringe, and no injury occurred.A photo and a sample were received for investigation; the up-close photo showed only the syringe, and the sample received included two pack inserts and two syringes, with both syringes having an identical oval-shaped hole in the same location on the rim of the barrel as shown in the photo.The reported issue was confirmed.Device history records were reviewed with no non-conformances noted, the pack build was reviewed with no issues identified that would likely contribute to the reported issue, and the root cause was determined to be likely a vendor-related product issue originating from the component manufacturing process; the vendor reviewed the dhr, found no issues or nonconformances, confirmed a perforation in the barrel and a deformed tip, and believed it occurred during the injection molding process of production.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: LEFT HEART KIT WRO-LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL
• Manufacturer Contact: vamshi pinnamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50721162
• Report Number: 1417592-2026-36426
• Device Sequence Number: 13303616
• Product Code: OEZ
• UDI-Device Identifier: 10195327427702
• UDI-Public: 10195327427702
• 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): 09/07/2026

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: DYNJ41865D
• Device Lot Number: 25HBU816
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/02/2025
• 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: 10/30/2025
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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