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

Catalog Number	DYNJ81593A
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the stopcocks that are in the packs seem to allow air to be pulled in when a syringe is pulling saline or contrast through it.They have noticed contrast leaking through the back of the turn knob.".
Additional Manufacturer Narrative
The account reported finding stopcocks pulling in air, and the customer reported contrast leaking through the back of the turn knob.A photo and a sample were received for investigation; a video confirmed that the stopcock during use was leaking fluids onto the surface, and closer inspection found the middle compartment of the stopcock has a crack in its surface, likely causing the leakage.The reported problem was confirmed.The item is received from the vendor and is not altered during the kit assembly process; the nature of the damage indicates a potential molding defect, and the component manufacturing facility identified that the leaking is caused by a mold deviation which leads to uneven wall thickness of the item.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-BASIC CARDIAC 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: 50856394
• Report Number: 1417592-2026-47872
• Device Sequence Number: 18625933
• Product Code: OEZ
• UDI-Device Identifier: 40195327325269
• UDI-Public: 40195327325269
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/22/2026

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: DYNJ81593A
• Device Lot Number: 23EBA370
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/22/2023
• 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: 12/27/2022
• Initial Report FDA Received Date: 09/22/2026
• 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