MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 12.5FX18CM LT HEMO-CATH; HEMO-CATH LT HEMODIALYSIS CATHETER

Model Number	MC101242
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.The device is being 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
Noted pinhole in red external lumen of hemo-cath.Catheter was removed and replaced.No adverse clinical consequences to the patient were reported.
Additional Manufacturer Narrative
The hemo-cath was returned for evaluation.Visual inspection confirms the complaint as two leaks were noted on the arterial extension approximately 4 cm from the end of the luer.The two leaks are 180 degrees from each other.The contract manufacturer conducted a review of the manufacture records for the catheter lot number reported.Their investigation revealed the device was manufactured and inspected according to specification with no non-conformance's or abnormalities.The process includes a 100% leak test performed as a last step in the manufacture process.This test would have detected any leaks, holes, or weak spots if they had existed at the time of manufacture.The device was implanted for more than three months prior to the event.We are unable to determine the cause or factors that may have contributed to this event.In the past similar holes in the extension tubing were determined to be caused by the user clamping over the stylet or guidewire during the insertion procedure.The instructions for use (ifu) contains the following precautions: clamping of the tubing repeatedly in the same location may weaken tubing.Avoid clamping near the luers and hub of the catheter.Do not clamp over guidewire or stylet - tubing may become damaged.Examine catheter lumen and extensions before and after each treatment for damage.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: 12.5FX18CM LT HEMO-CATH
• Common Device Name: HEMO-CATH 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: 12798552
• Report Number: 2518902-2021-00064
• Device Sequence Number: 20245223
• Product Code: MSD
• UDI-Device Identifier: 00884908082999
• UDI-Public: 884908082999
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2022

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: 07/30/2025
• Device Model Number: MC101242
• Device Catalogue Number: MC101242
• Device Lot Number: MPDL180 S2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2020
• 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: 11 YR
• Patient Sex: Male
• Patient Weight: 34 KG