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

Catalog Number	DYNJ44065C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the rotating adapter end broke off from the manifold once during prep and twice while connected to the catheter to inject coronaries.".
Additional Manufacturer Narrative
The customer contact reported that the rotating adapter end broke off from the manifold during prep and while connected to the catheter to inject coronaries; there was a minimal amount of blood from the patient lost that was quickly stopped, and the patient was not harmed.No sample or photo was received for the investigation, finished good production records were reviewed, and there were no line down situations, deviations, run-withouts, or non-conformance reports that might have had an impact on this issue.Based on the complaint details, the issue could not be confirmed and a root cause could not be determined because a sample or detailed pictures were not received.This complaint was provided to the component manufacturing facility for further evaluation, and the supplier quality team will monitor this issue for trending purposes.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-CARDIAC LEG PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joseph weiske ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50732367
• Report Number: 1417592-2026-36806
• Device Sequence Number: 13411545
• Product Code: OEZ
• UDI-Device Identifier: 40195327080632
• UDI-Public: 40195327080632
• 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): 09/08/2026

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: DYNJ44065C
• Device Lot Number: 23IBB714
• Was Device Available for Evaluation?: Yes
• 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: 10/30/2023
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (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