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
Arrived in the home to do cvad maintenance.Appeared to be either 100% air or 100% fluid.No air bubbles seen.Writer removed the current cap, then attached flush syringe with new primed cap and writer pulled back.Writer noted air come into the syringe with no resistance and then small fluid with air in between.Client states he also had air in his line last week and had to go into cci for maintenance.Line removed.
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 hemo cath catheter was returned for evaluation with the end caps in place and an orange "do not use" sticker on the arterial extension.The device was flushed and aspirated, no leaks or other issues were noted.The end caps appear to be injectable end caps.Under magnification a crack was noted on the septum portion of the cap.A pin was run across the septum perpendicular to the crack, revealing the crack is actually a hole.Water was then inserted into the opposite end of the end cap and was noted to leak from the hole in the septum.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 conducted a review of the manufacture records.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 (b)(6) 2021 to (b)(6) 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
• 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: 15986956
• Report Number: 2518902-2022-00072
• Device Sequence Number: 5961827
• 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 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: MQFL200
• 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: 04/26/2022
• 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