MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 12.5FX24CM HEMO-CATH; HEMO-CATH HEMODIALYSIS CATHETER

Model Number	MC101243
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are currently waiting for additional information and device return.Our investigation is ongoing.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 available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Patient was implanted with the hemo-cath catheter on (b)(6) 2021.On (b)(6) 2021 the device was removed and replaced due to air in the line.Patient reports air in the line of the second device as well.A home care nurse reports removing approximately 1.5 mls of air from the line.
Additional Manufacturer Narrative
One device was returned for evaluation in two pieces.The main catheter (hub and extensions) was returned with approximately 10cm of the lumen attached.The rotating suture wing was not assembled on the hub and was not returned.It was also noted that a suture was tied to the lumen approximately 4.5cm from the hub and 0.5cm from the cuff.An additional 14cm of the lumen was also returned.A functional evaluation was performed.With the distal end of the lumen clamped the arterial lumen was flushed.Leakage was noted to be coming from under the cuff between the cuff near where the suture is tied around the lumen.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.This catheter is subjected to a leak test during the final step of the manufacture process.This test would have detected any catheter leak.A definitive root cause cannot be determined but is not likely related to the manufacture process.The sutures tied around the catheter lumen may have been a contributing factor.The instructions for use contain the following precautions.Suture insertion site closed.Suture the catheter to the skin using the suture wing.Do not suture the catheter tubing.

• Brand Name: 12.5FX24CM HEMO-CATH
• Common Device Name: HEMO-CATH HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 11752033
• Report Number: 2518902-2021-00024
• Device Sequence Number: 4138634
• Product Code: MSD
• UDI-Device Identifier: 00884908083002
• UDI-Public: 884908083002
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2021

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: 06/22/2025
• Device Model Number: MC101243
• Device Catalogue Number: MC101243
• Device Lot Number: MPJX020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 06/04/2021
• 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