MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 10F X 18CM SPLIT CATH XL; SPLIT CATH XL HEMODIALYSIS CATHETER

Model Number	ASPC18P-XL
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
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
The 2.5 flow permcath catheter was used for contrast injection.In the blue luer it was used with a 3-way faucet, since the red route received saline solution.The red luer was closed and the blue luer was opened, the tap was turned on at the connection.When performing the test with serum in the injector with flow 2.5, the taps and the white part of the catheter came out.
Additional Manufacturer Narrative
The device was not returned for evaluation as it was discarded at the facility.A photograph was provided showing one luer in a bag with one cap.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation showed all components of the catheter were manufactured, inspected, and assembled according to specification with no non-conformances or abnormalities.The information provided indicated the failure occurred during a contrast injection study.The device reported in this complaint is not indicated or approved for a power injection study.Use of the device for this purpose is considered off-label use.The instructions for use state: the medcomp® pediatric split cath® xl is indicated for use in attaining long-term vascular access for hemodialysis and apheresis.This catheter is intended for long-term vascular access only and should not be used for any purpose other than indicated in these instructions.

• Brand Name: 10F X 18CM SPLIT CATH XL
• Common Device Name: SPLIT CATH XL HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 11819788
• Report Number: 2518902-2021-00026
• Device Sequence Number: 19645641
• Product Code: MSD
• UDI-Device Identifier: 00884908003437
• UDI-Public: 884908003437
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

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: 12/20/2022
• Device Model Number: ASPC18P-XL
• Device Catalogue Number: ASPC18P-XL
• Device Lot Number: MPHF800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 06/11/2021
• 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