MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 10F X 24CM SPLIT CATH; SPLIT CATH XL

Model Number	ASPC24P-XL
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device sample is entering the investigation process.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 avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Possible fistula within line problems with low venous pressure on hd machine.Parents saw tiny air bubble go in through blue lumen and come straight out the red lumen.Also, blood should come out of the arterial lumen very dark as it should have had no mixture with saline however using this line the blood came out the arterial lumen very obviously mixed with saline.Thought to be some communication between arterial lumen and venous lumen within the line itself.
Additional Manufacturer Narrative
The contract manufacturer conducted an investigation of the returned device, as well as a review of the manufacture process of the device.It was noted that the device evaluation occurred after the decontamination process which would have dislodged any dried blood or other obstructions that may have contributed to this event.All relevant measurements taken revealed the device was within specification.A review of the manufacture process revealed a lumen patency and leak test is performed at 100%.The leak test is the final step of the manufacture process prior to packaging and will detect very tiny holes, tears, and gaps in the device.The device was implanted and in use for more than 20 months prior to this issue a definitive root cause cannot be determined but is most likely not manufacture related.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: 10F X 24CM SPLIT CATH
• Common Device Name: SPLIT CATH XL
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 10308201
• Report Number: 2518902-2020-00031
• Device Sequence Number: 10963505
• Product Code: MSD
• UDI-Device Identifier: 00884908003581
• UDI-Public: 884908003581
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K020936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2020

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 Model Number: ASPC24P-XL
• Device Catalogue Number: ASPC24P-XL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 11/02/2020
• 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: 3 YR
• Patient Weight: 16