FDA Adverse Event Malfunction Summary report: N

4 FR PICC BASIC TRAY W/M

MDR report key: 390059 · Received April 19, 2002

Report

Report Number
1720496-2002-00074
Event Type
Malfunction
Date Received
April 19, 2002
Report Date
March 18, 2002
Manufacturer
BARD REYNOSA S.A. DE C.V.
Product Code
DQO
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THE DR PLACED ONE PICC NOTICED A LEAK IN THE PICC, NOTICED LEAK THAT WOULD HAVE BEEN SUB-Q IN THE PT HAD IT BEEN PLACED. NO OTHER INFO PROVIDED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 4 FR PICC BASIC TRAY W/M LONG TERM INTRAVASCULAR CATHETER DQO BARD REYNOSA S.A. DE C.V. 7755405 22DL5847

Patients

Seq Age Sex Outcome Treatment
1 UNKNOWN Other