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

Model Number ASPC40-3E.

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2018

Event Type  malfunction  

Event Description

Hole in hub.

• Brand Name: 14F X 40CMSPLIT CATH III
• Type of Device: SPLIT CATH III
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDCOMP; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 8214662
• MDR Text Key: 132783193
• Report Number: 2518902-2019-00002
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908004243
• UDI-Public: 884908004243
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K051280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 01/03/2019
• Supplement Dates Manufacturer Received: 12/04/2018
• Supplement Dates FDA Received: 04/16/2019
• Date Device Manufactured: 09/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention