FDA Adverse Event Other Summary report: N

2.0 FR PICC

MDR report key: 1406507 · Received June 18, 2009

Report

Report Number: 2925153-2009-00003
Event Type: Other
Date Received: June 18, 2009
Date of Event: May 15, 2009
Report Date: June 15, 2009
Manufacturer: NEOMEDICAL, INC.
Product Code: LJS
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE 2.0 FR CATHETER IS A SILICONE CATHETER AND THE IFU GIVES ADVICE CONCERNING THE USE OF THE PRODUCT. THE PRODUCT IFU GIVES CLEAR DIRECTIONS CONCERNING USE OF CATHETER WITH BREAK-AWAY INTRODUCERS / NEEDLES: IT STATES "NEVER ATTEMPT TO PULL THE CATHETER BACK THROUGH A NEEDLE." THE USED SAMPLE WAS SAID TO BE AVAILABLE; HOWEVER, TO DATE IT HAS NOT BEEN RETURNED TO NEOMEDICAL.

Description of Event or Problem · 1

BASED ON THE REPORT, RECEIVED AT NEOMEDICAL ON (B)(6) 2009, " PICC PLACEMENT WAS DONE IN RIGHT SAPHENOUS VEIN OF THE RIGHT FOOT. CATHETER ADVANCED, GOOD BLOOD RETURN. INTRODUCER WAS PEEL-AWAY TYPE AND WHEN IT WAS PEELED OFF, THE CATHETER WAS FOUND TO BE SEVERED. THE INSERTED PORTION OF THE CATHETER WAS NOW NO LONGER VISIBLE ON THE OUTSIDE OF THE BODY. THE REMAINING CATHETER WAS REMOVED (B)(6) 2009 AT ANOTHER FACILITY. THE CURRENT STATUS OF THE PATIENT IS GOOD. NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE. (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	2.0 FR PICC	V-CATH	LJS	NEOMEDICAL, INC.	350-10	0121

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention