MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-CARDIAC CATH 3 PORT PROCEDURE

Model Number	DYNJ40951C
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a control syringe component broke during use and cut a physician's hand.
Additional Manufacturer Narrative
It was reported that a control syringe component broke while a physician was injecting contrast during an angiography.Reportedly, the plunger flange broke off and the remaining sharp edges cut through the physician's glove and caused a superficial cut on his right hand between the thumb and the index finger on the palmer side.There was a minor delay in the procedure as the physician assessed his hand, re-scrubbed, and re-gloved.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.A sample was returned for evaluation and the syringe was observed to be broken at the plunger where it would be pushed down.The root cause of the break was determined to be user caused and due to the pressure placed on the component while injecting contrast.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.

• Common Device Name: DBD-CARDIAC CATH 3 PORT PROCEDURE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 18865191
• Report Number: 1423395-2024-00135
• Device Sequence Number: 20866982
• Product Code: OES
• UDI-Device Identifier: 40889942684763
• UDI-Public: 40889942684763
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2024

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 Model Number: DYNJ40951C
• Device Lot Number: 22CBZ028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 03/08/2024
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male