MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. DUO-FLOW® SOFT-LINE®; ST HEMODIALYSIS CATHETER

Model Number	DT74M
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.Currently waiting for additional information.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Hd line was dislodged while moving ccrt circuit in preparation for head ct.Pt is a liver transplant on crrt that required a head ct for increasing ammonia.Pt laying low in bed, ccrt lined closer to hob so lines were taut.The crrt circuit was move and they did not communicate the plan prior to moving the patient.Moving the circuit cause tension on the line causing it to dislodge.
Additional Manufacturer Narrative
The information was reported directly to medcomp from the fda via a medsun report.The reporting facility was contacted for additional information regarding the device and the event.No communication was received.No further information was received.Without sufficient information, or an evaluation of the device involved, we are unable to determine the root cause or factors that may have contributed to this event.The report indicated the failure occurred when the patient was being moved in the bed, with no warning to the other staff.It is possible the catheter was pulled and stressed beyond the design capabilities.

• Brand Name: DUO-FLOW® SOFT-LINE®
• Common Device Name: ST HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: susan smith ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 21251533
• Report Number: 2518902-2025-00004
• Device Sequence Number: 9179693
• Product Code: MPB
• UDI-Device Identifier: 00884908143393
• UDI-Public: 00884908143393
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K982511
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: DT74M
• Device Catalogue Number: DT74M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 6 MO
• Patient Sex: Female