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

Model Number	MC101243
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Air in cvc line, no blood return or able to flush after taking air out.Alteplase administered to line.
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.
Additional Manufacturer Narrative
The device involved in the incident was not returned as it remains implanted in the patient.No photographs were provided.The report indicated that the catheter involved did not leak and was implanted for 3 weeks before the issue was noted.Without an evaluation of the device a definitive root cause could not be determined.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 and thoroughly investigated.The devices were not returned for evaluation as they remained implanted in the patients.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 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
• 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: 15986995
• Report Number: 2518902-2022-00073
• Device Sequence Number: 5922835
• 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?: 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: 12/14/2022
• 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): 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