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

Model Number	MC101243
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Large air bubble noted in the blue lumen extension of client's dual lumen central line.Catheter remains implanted.
Additional Manufacturer Narrative
The device involved in the incident was not returned as it remains implanted in the patient.The report indicated that the catheter involved did not leak and was implanted for 11 days before the issue was noted.Photograph provided confirm the complaint as an air bubble was noted in the venous extension tube.Previous events reported by same facility suggested the end caps were the root cause of the issue.Those end caps are not manufactured or supplied by medcomp.The end caps provided in the kits are one time use, are not meant to be injected through and should be changed after each treatment.If this was followed the end caps provided in the kits could not be the cause of the air bubbles in the extensions.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the devices were manufactured according to specification with no non-conformances or abnormalities.The manufacture process includes a leak test as well as a test for air bubbles.The catheter female luers are manufactured to the iso standard.They are universal female luers and will mate with any universal male luer of bloodlines, syringes, end caps, etc.If they are also manufactured to the iso standard.These end caps are packaged in all of medcomp long- and short-term hemodialysis/apheresis catheter kits.Without an evaluation of the device involved we are unable to determine if the catheter contributed to the problem.After evaluating the information provided, we believe it is unlikely the catheter is at fault.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: 15708705
• Report Number: 2518902-2022-00063
• Device Sequence Number: 17764863
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/10/2026
• Device Model Number: MC101243
• Device Catalogue Number: MC101243
• Device Lot Number: MQCF520
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2022
• 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
• Patient Sex: Male