PICC SET: 2-L 16 GA X 19 - 1/2

MDR report key: 3823739 · Received February 20, 2014

Report

Report Number: 1036844-2014-00076
Event Type: Malfunction
Date Received: February 20, 2014
Date of Event: December 17, 2013
Report Date: February 14, 2014
Manufacturer: ARROW INTL., INC.
Product Code: LJS
PMA / PMN Number: K930129
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PT INVOLVED WAS A (B)(6) FEMALE WITH ABDOMINAL PAIN. THE PT HAS A HISTORY OF ACUTE PANCREATITIS, CARDIAC FAILURE, CORONARY DISEASE, PACEMAKER; HTA REQUIRES USE OF A PICC CATHETER. THE PT WAS TAKEN TO THE TAC ROOM PRIOR TO CONTRAST INJECTION, AND THE CATHETER PLACED IN THE PT'S RIGHT SUBCLAVIAN WAS REVISED MANUALLY WITH SALINE. IT WAS AT THAT TIME IN IMAGERY DX THAT A LEAK WAS OBSERVED IN THE BLUE UNION BETWEEN THE CATHETER AND THE LUMENS. AS A RESULT, A NEW KIT WAS OPENED AND USED WITHOUT ISSUE. A DELAY WAS REPORTED, HOWEVER, THERE WERE NO ADDITIONAL COMPLICATIONS TO THE PT AS A RESULT OF THIS OCCURRENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
106569	PICC SET: 2-L 16 GA X 19 - 1/2	PERIPHERALLY INSERTED CENTRAL CATHETERS	LJS	ARROW INTL., INC.		RF3052166

Patients

Seq	Age	Sex	Outcome	Treatment
1	84 YR