MAUDE Adverse Event Report: MEDCOMP 14F X 24CM SPLIT CATH III

Model Number	ASPC24-3
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/19/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Valved peelaway valve malfunctioned.Patient was bleeding a lot.

• Brand Name: 14F X 24CM SPLIT CATH III
• Common Device Name: SPLIT CATH III
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 6479723
• Report Number: 2518902-2017-00014
• Device Sequence Number: 1054392
• Product Code: MSD
• UDI-Device Identifier: 00884908003475
• UDI-Public: 884908003475
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/11/2017

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: Health Professional
• Device Model Number: ASPC24-3
• Device Catalogue Number: ASPC24-3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2017
• Initial Report FDA Received Date: 04/11/2017
• 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