MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 14F X 28CM SPLIT CATH III

Model Number	ASPC28-3E.
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Currently waiting for the sample to be returned for evaluation.Once the investigation is complete a final report will be submitted.
Event or Problem Description
After having connected the patient air bubble alarm from the dialysis machine.Lots of bubbles on the arterial extension.Treatment interruption in order to check the luer lock connection: ok no issue.Treatment continuity but new air bubble alarm.Visually, air bubbles were drawn directly into the arterial extension.Treatment interruption: line disconnection, rinsing with water, insertion of tips.Visually, blood was flowing slightly between the lumen and the extension adaptor.Removal of the catheter then insertion of a new.The catheter seems to have a tear.The patient is now in good condition.
Additional Manufacturer Narrative
The split cath was returned for evaluation in two (2) pieces.Approximately 5.3 cm of the lumen remains attached to the hub.The remainder of the lumen was also received.The device was both flushed and aspirated with no issues noted.No leaks, bubbles, or back flow were noted.No tear was noted.Issue cannot be replicated with the returned device.Complaint cannot be confirmed.The issue may have been with the bloodline used during the treatment and not with the catheter.The catheter was implanted and functioned for over 2.5 years with no reported problems.New bloodlines are used every treatment.Device was used for treatment, not diagnosis.If information is obtained that was not avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 14F X 28CM SPLIT CATH III
• Common Device Name: SPLIT CATH III
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 9836862
• Report Number: 2518902-2020-00018
• Device Sequence Number: 11534919
• Product Code: MSD
• UDI-Device Identifier: 00884908003710
• UDI-Public: 884908003710
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K040318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

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: 07/04/2021
• Device Model Number: ASPC28-3E.
• Device Catalogue Number: ASPC28-3E.
• Device Lot Number: MHQZ410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR