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

Catalog Number	DYNJ40904F
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the manifold broke again during use- luer lock end is popping off.".
Additional Manufacturer Narrative
The account reported a broken manifold, and the customer reported another manifold break with a simple hand injection during a heart cath in the same area as before on the luer lock end.A photo and a sample were received; the account provided a picture of a sample of the broken manifold and a syringe, no other manifold connections or parts of the kit were provided, and the sample was used and provided in a biohazard bag.The luer lock was completely broken off of the manifold with no other cracks noted on the item, confirming the reported issue.Based on the complaint details, the root cause is considered to be a vendor product issue relating to the component manufacturing process; this complaint has been provided to the component manufacturing facility for further evaluation, and there was no confirmed medical intervention or serious injury reported related to this incident.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-CATH PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: urmi parekh ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50885009
• Report Number: 1417592-2026-50120
• Device Sequence Number: 10664292
• Product Code: OES
• UDI-Device Identifier: 40195327024520
• UDI-Public: 40195327024520
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 09/24/2026

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: DYNJ40904F
• Device Lot Number: 23HME127
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/21/2023
• 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: 12/11/2023
• Initial Report FDA Received Date: 09/24/2026
• 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