MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 10FX70CM BIOFLEX TESIO; BIO-FLEX TESIO

Model Number	BFR1070KD-A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994)
Date of Event	12/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Currently waiting for the device to be returned for evaluation.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
Catheter was placed in the left femoral vein.Patient started to have burning sensation in groin area, on the same day local hematoma appeared.Patient went to operating room, and on ctc scan with contrast it was seen 2 ruptures on catheter.First rupture was in the tunnel, and second rupture was at the connection of cuff and catheter.
Additional Manufacturer Narrative
Although reported the device would be returned for evaluation, no device was received and no photographs were provided.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured, assembled, and inspected according to specification with no non-conformances or abnormalities.The manufacture process includes a 100% leak test performed as the last step in the process.This test would have detected any holes, leaks, or weak areas if they had existed at the time of manufacture.Without an evaluation of the device a root cause cannot be determined.The catheter was placed in the femoral vein and was implanted for 1 years 3 months prior to the incident.The femoral vein is not indicated as a placement site in the instructions for use.A literature review indicates the femoral vein provides an alternative access site for insertion of tunneled hemodialysis catheters when conventional sites are not available.However, tunneled femoral hemodialysis catheters have low primary patency rates and significant complications.

• Brand Name: 10FX70CM BIOFLEX TESIO
• Common Device Name: BIO-FLEX TESIO
• 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: 13022219
• Report Number: 2518902-2021-00071
• Device Sequence Number: 4948738
• Product Code: MSD
• UDI-Device Identifier: 00884908004977
• UDI-Public: 884908004977
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2022

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/28/2022
• Device Model Number: BFR1070KD-A
• Device Catalogue Number: BFR1070KD-A
• Device Lot Number: MLKW610
• 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: 12/16/2021
• Supplement Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2018
• 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 Sex: Female