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	11/02/2022
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
10-12 bubbles in clear portion of broviac line (between the clamps and the insertion site).
Additional Manufacturer Narrative
The 12.5f hemo cath was returned for evaluation with end caps in place.Visual inspection revealed no obvious defects with the device.The device was flushed and aspirated with no issues and no leaks were noted.Under magnification small cracks can be seen on the septum of the end caps.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.Similar issues were reported by the same facilities 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.As the evaluation of these latest complaints has again revealed the root cause is the end cap and not the catheter, medcomp again advised that the manufacturer of the end cap be notified of these events.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: 15987016
• Report Number: 2518902-2022-00074
• Device Sequence Number: 17694442
• 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
• 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?: Device Returned to Manufacturer
• 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: 12/14/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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