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

Model Number MC641522

Device Problem Disconnection (1171)

Patient Problem Respiratory Insufficiency (4462)

Event Date 01/01/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 308031576
• Report Number: 2518902-2023-00010
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908084016
• UDI-Public: 00884908084016
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 2008 HEMODIALYSIS T MACHINE; COMBISET BLOOD LINES; GRANUFLO DIALYSATE G2251
• Patient Outcome(s): Hospitalization
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Race: White