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

Model Number	MC101242
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are currently waiting for the device to be returned for evaluation.A follow up report will be submitted when the investigation is complete.Device was used for treatment, not diagnosis.If information is obtained that was not avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Catheter was exchanged over a guidewire but during hemodialysis the same day small holes were noted in the extension line, resulting in blood leaking.
Additional Manufacturer Narrative
The arterial luer was returned with approximately 3 cm of extension tubing attached.Visual inspection confirmed the complaint.The distal end of the tubing was clamped with hemostat and flushed with water.A small pin hole leak was noted approximately 2 cm from the end of the luer.When viewed under magnification it appears the hole was created by an external puncture, such as a needle stick.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured according to specification with no non-conformances or abnormalities.The manufacture process includes a 100% leak test at the end of the process which would have detected the leak if it was present at that time.A root cause cannot be determined but is not likely related to the manufacture process.The instructions for use (ifu) contains the following precautions: do not use sharp instruments near the extension tubing or catheter lumen.Do not use scissors to remove dressing.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 HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 11465018
• Report Number: 2518902-2021-00015
• Device Sequence Number: 11670590
• Product Code: MSD
• UDI-Device Identifier: 00884908082999
• UDI-Public: 884908082999
• Combination Product (Y/N): N
• Initial Reporter Country: TK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2021

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: 01/25/2025
• Device Model Number: MC101242
• Device Catalogue Number: MC101242
• Device Lot Number: MPFB480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 13 YR