FDA Adverse Event Malfunction Summary report: N

PER-Q-CATH PLUS A SILICONE PERCUTANEOUS CVC

MDR report key: 1070582 · Received July 1, 2008

Report

Report Number
3006260740-2008-00025
Event Type
Malfunction
Date Received
July 1, 2008
Date of Event
June 3, 2008
Report Date
June 4, 2008
Manufacturer
C. R. BARD, INC. (BASD)
Product Code
LJS
PMA / PMN Number
K954104
Product Problem
Yes
Report Source
Manufacturer report
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.

Description of Event or Problem · 1

LINE PLACED IN PT. CATHETER SEPARATED FROM THE HUB.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PER-Q-CATH PLUS A SILICONE PERCUTANEOUS CVC LJS C. R. BARD, INC. (BASD) RERJ0345

Patients

Seq Age Sex Outcome Treatment
1 Required Intervention