FDA Adverse Event Malfunction Summary report: N

BARD ACCESS SYSTEMS

MDR report key: 1742956 · Received June 28, 2010

Report

Report Number
MW5016527
Event Type
Malfunction
Date Received
June 28, 2010
Date of Event
May 25, 2010
Report Date
June 22, 2010
Manufacturer
BARD ACCESS SYSTEMS
Product Code
LJS
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
IN, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

IV THERAPY WAS NOTIFIED BY A PHYSICIAN THAT "SOMETHING" WAS PICKED UP ON A CT SCAN THAT THOUGHT COULD BE A PIECE OF A PICC LINE THAT HAD BEEN INSERTED HERE ON (B)(6) 2010 (LEFT ARM). PT REPRESENTED ON (B)(6) AND PICC TIP WAS IDENTIFIED AT SUBCLAVIAN LEVEL, LABELED AS MID-LINE. SECOND PICC WAS PLACED ON (B)(6) 2010 DUE TO DECLINE IN PT'S CONDITION IN RIGHT ARM. STAFF NURSE REMOVED PICC (SUBCLAVIAN TIP) FROM LEFT ARM. ON (B)(6) 2010, AFTER CT SCAN, NOTIFIED THAT A FOREIGN OBJECT HAD BEEN IDENTIFIED IN REGION OF PULMONARY ARTERY. PICC TIP, GUIDE-WIRE. AFTER CONSULTATION WITH VASCULAR SURGEON AND INTERVENTIONAL RADIOLOGIST, IT WAS DETERMINED THAT ATTEMPTING TO RETRIEVE THE OBJECT AT THIS TIME WAS TOO RISKY DUE TO PT'S GENERALLY POOR CONDITION. PT EXPIRED ON (B)(6) 2010 AND OBJECT IN QUESTION WAS RETRIEVED BY PATHOLOGY AND IDENTIFIED AS GUIDE WIRE APPROX 6M. IV THERAPY INSERTS PICC LINES THROUGH A PLASTIC DEVICE NOT THROUGH A NEEDLE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BARD ACCESS SYSTEMS PICC LINE LJS BARD ACCESS SYSTEMS REUB0350

Patients

Seq Age Sex Outcome Treatment
1 73 YR