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

Catalog Number	DYNJ61294D
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "issue here is the stopcock (3 way) threaded part, when they withdraw blood from a port there appears to be a leak in the posterior end of the stopcock that introduces air.".
Additional Manufacturer Narrative
The customer reported a stopcock issue where, when they withdraw blood from a port, there appears to be a leak in the posterior end of the stopcock that introduces air.A sample was received for investigation; the account returned 4 stopcocks, one used and three unused, and using the magnifying camera it was confirmed that all stopcocks had cracks in their interior molds, which could lead to leaking when in use.The reported problem was confirmed.Based on the complaint details, the root cause is considered to be a vendor product issue relating to the component manufacturing process, and the complaint was provided to the component manufacturing facility for further evaluation.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: sangameswaran saravanakumar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50872629
• Report Number: 1417592-2026-49333
• Device Sequence Number: 10674123
• 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): 09/23/2026

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: 23JBL540
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/05/2023
• 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: 11/17/2023
• Initial Report FDA Received Date: 09/23/2026
• 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