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

Model Number	MC101243
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Home visit to do initial dressing change 24 hours post insertion for cvad.Bubbles noted in both lumens of cvad.Client called cci and they informed him the bubbles will be aspirated at his next maintenance/flush.Line removed for suspected obstruction of the distal (blue) lumen.With respect to the blue lumen, attempts to withdraw blood into the syringe were unsuccessful.Approximately 10 cc of omnipaque were injected, which swiftly opacified the catheter.Although some free flow of contrast media occurred, accumulation was observed around the catheter tip, confirming obstruction by a one- way flap/valve mechanism.With respect to the red lumen, blood withdrawal was normal and the catheter flushed freely.Catheter removal and replacement were suggested and completed - sample not retained.
Additional Manufacturer Narrative
The device involved in the incident was not returned for evaluation and no photographs were provided.Devices from the same lot were returned for similar events reporting the same issue.Those devices were evaluated with no abnormalities or leaks noted.The end caps returned with those devices were also evaluated and, under magnification, cracks/holes were noted in the septum of the end caps.It was determined the root cause of these issues, including the event in this complaint, are related to the end caps and not the catheter.The end caps provided by medcomp in the insertion kits are one time use, are not meant to be injected through and should be replaced after each treatment.If this was followed, the end caps provided in the kits could not be a contributing factor of the air bubbles in the extensions.The contract manufacturer of the catheter conducted a review of the manufacture records for the lot numbers reported.Their investigation revealed the devices were manufactured and inspected according to specification with no non-conformances or abnormalities.The initial reporter of this event also reported similar issues from april 29, 2021 to july 13, 2021.Most of those devices were also not returned for evaluation as they remained implanted.The reporting facilities in those complaints report the issue was resolved when the end caps were replaced.It was determined at that time the root cause of these issues was related to the end cap and not the catheter.Medcomp advised reporter at that time that the manufacturer of the end caps should be notified of the event.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: 12.5FX24CM 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: 16003420
• Report Number: 2518902-2022-00075
• Device Sequence Number: 6577826
• Product Code: MSD
• UDI-Device Identifier: 00884908083002
• UDI-Public: 00884908083002
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2023

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: 09/10/2026
• Device Model Number: MC101243
• Device Catalogue Number: MC101243
• Device Lot Number: MQBD150 S2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• 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 Sex: Unknown