MAUDE Adverse Event Report: MEDCOMP 14F X 40CMSPLIT CATH III

Model Number	ASPC40-3E.
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Hole in hub.

• Brand Name: 14F X 40CMSPLIT CATH III
• Common Device Name: SPLIT CATH III
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8214662
• Report Number: 2518902-2019-00002
• Device Sequence Number: 14019988
• Product Code: MSD
• UDI-Device Identifier: 00884908004243
• UDI-Public: 884908004243
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K051280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2019

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: 09/11/2021
• Device Model Number: ASPC40-3E.
• Device Catalogue Number: ASPC40-3E.
• Device Lot Number: MHVC450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 04/16/2019
• 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