MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 14.5FX24CM HEMO-FLOW DBL LMN; HEMO-FLOW LT HEMODIALYSIS CATHETER

Model Number	HFS 24
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are 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
A leak was noted in the hub of the device.
Additional Manufacturer Narrative
One 14.5f x 24 cm hemo-flow catheter was returned for evaluation.A visual examination revealed no obvious defects or abnormalities.When performing a functional evaluation, a leak at the arterial lumen to hub joint was noted.Under magnification the catheter hub appears slightly deformed at the location of the leak.There is also a minor separation on the knit line that does not leak.A supplier corrective action request was issued to the contract manufacturer for this event.The contract manufacturer's attempt to replicate the failure mode was unsuccessful.The investigation revealed the root cause was most likely an intermittent defect that should be detected during the 100% leak test operation of finished product.The operator may have failed to properly follow the leak test procedure.As a result, actions have been taken to minimize this type of occurrence.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.

• Brand Name: 14.5FX24CM HEMO-FLOW DBL LMN
• Common Device Name: HEMO-FLOW 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: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 16137712
• Report Number: 2518902-2023-00004
• Device Sequence Number: 20461051
• Product Code: MSD
• UDI-Device Identifier: 00884908017175
• UDI-Public: 00884908017175
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/13/2023

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/08/2024
• Device Model Number: HFS 24
• Device Catalogue Number: HFS 24
• Device Lot Number: MQKK360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2022
• 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: 27 YR
• Patient Sex: Male