MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 15.5F X 28CM PC HEMO-FLOW XF; HEMO-FLOW XF LT HEMODIALYSIS CATHETER

Model Number	MC641522
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device involved in the incident was not available for evaluation.The catheter was implanted for over 3 years with no repairs or prior malfunction (per the facility).Without an evaluation of the catheter involved, we are unable to determine the cause of the event.However, since the catheter was implanted for over 3 years with no reported problems, it is unlikely to be manufacture related.The female luers are manufactured to the iso standard (iso 594-2:1998).They are universal female luers and will mate with any universal male luer of the bloodlines, syringes, injection caps, etc.If they are also manufactured to the iso standard.The blood lines, not manufactured by medcomp, should also be evaluated.The instructions for use include the following catheter precaution."to prevent accidents, assure the security of all caps and bloodline connections prior to and between treatments." device was used for treatment, not diagnosis.If information is obtained that was not available for the initial, a follow-up will be filed as appropriate.
Event or Problem Description
Patient had uneventful initiation of treatment at outpatient dialysis setting.Cvc blood lines reversed to achieve clinical parameters at onset of treatment.One hour into treatment rn responded to alarm for patient on machine, pt symptomatic with cvc separation.Staff reconnected line and noticed air in arterial limb of lumen.Staff withdrew air with sterile syringe, and send to ed.Patient discharged home with original catheter without intervention after head ct.Nurse practitioner ordered patient for new cvc placement.Cvc in use at time of event was placed on (b)(6) 2019 without any repairs or prior malfunction.

• Brand Name: 15.5F X 28CM PC HEMO-FLOW XF
• Common Device Name: HEMO-FLOW XF LT 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: 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 16233829
• Report Number: 2518902-2023-00010
• Device Sequence Number: 6390592
• Product Code: MSD
• UDI-Device Identifier: 00884908084016
• UDI-Public: 00884908084016
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/24/2023

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: Health Professional
• Device Expiration Date: 10/25/2021
• Device Model Number: MC641522
• Device Catalogue Number: MC641522
• Device Lot Number: MNLG570 S2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2008 HEMODIALYSIS T MACHINE; COMBISET BLOOD LINES; GRANUFLO DIALYSATE G2251
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Race: White