FDA Adverse Event Malfunction Summary report: N

3.5 FRENCH 60 CM DUAL

MDR report key: 1153404 · Received August 7, 2008

Report

Report Number
1153404
Event Type
Malfunction
Date Received
August 7, 2008
Date of Event
June 21, 2008
Report Date
June 26, 2008
Manufacturer
BECTON DICKINSON
Product Code
LJS
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MA, US

Narratives

Description of Event or Problem · 1

THE NIGHTTIME NURSE REPORTED THAT THE CATH 3.5 FRENCH 60 CM DUAL PICC WAS LEAKING. AFTER THE IV NURSE ASSESSED THE DEVICE, IT WAS DETERMINED AFTER FLUSHING THE LINE WITH NORMAL SALINE, THAT THE LINE WAS IN FACT DEFECTIVE AND IT WAS LEAKING AT THE TUBING SITE. STAFF RECORDED THE LOT NUMBER AND CONFISCATED THE ACTUAL PICC AFTER IT WAS REMOVED. THERE WAS NO HARM DONE TO THE PATIENT, AND AFTER REMOVAL, THE PHYSICIAN TEAM DECIDED THAT IT WAS NO LONGER NECESSARY FOR THE PATIENT TO HAVE PICC LINE. THE LOT NUMBER 7170231 WAS RETURNED TO THE MANUFACTURER. WE THEN REALIZED THAT A SECOND LOT NUMBER IN-HOUSE (LOT 7339504, CATALOG NUMBER 384467) WAS INVOLVED IN A PRODUCT RECALL. THE HOSPITAL'S MATERIAL MANAGEMENT DEPARTMENT ISSUED AN IN-HOUSE PRODUCT RECALL. THE HOSPITAL IS AWAITING THE MANUFACTURER'S RESPONSE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 3.5 FRENCH 60 CM DUAL CATHETER, PICC LJS BECTON DICKINSON * 7170231

Patients

Seq Age Sex Outcome Treatment
1 13 YR