PICC SET: 2-LUMEN 4 FR X 19-1/2" (50 CM)

MDR report key: 5242901 · Received November 23, 2015

Report

Report Number: 1036844-2015-00539
Event Type: Malfunction
Date Received: November 23, 2015
Date of Event: September 23, 2015
Report Date: November 18, 2015
Manufacturer: ARROW INTERNATIONAL INC.
Product Code: LJS
PMA / PMN Number: K042126
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

(B)(4). BASED UPON THE LIMITED INITIAL INFORMATION WE DETERMINED THAT THIS EVENT WAS A REPORTABLE MALFUNCTION. HOWEVER, A SAMPLE WAS RECEIVED AND EXAMINED AND THE CONDITION OF THAT SAMPLE ALTERED OUR INTERPRETATION OF THE COMPLAINT INFORMATION. WE NO LONGER CONSIDER THIS EVENT TO BE REPORTABLE AND REQUEST TO WITHDRAW THE INITIAL REPORT. THE SAMPLE WAS OBSERVED TO BE UNUSED AND THE ISSUE RELATED TO PACKAGING.

Description of Event or Problem · 1

IT WAS REPORTED THAT WHEN THE CATHETER WAS REMOVED AND REVIEWED, IT WAS IDENTIFIED THAT THE "DISTAL LUMEN IS IN POOR CONDITION." AND "THE CATHETER IS NOT USED FOR INFECTION IN LUMEN."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
773159	PICC SET: 2-LUMEN 4 FR X 19-1/2" (50 CM)	PERIPHERALLY INSERTED CATHETER PRODU	LJS	ARROW INTERNATIONAL INC.		23F15C2142

Patients

Seq	Age	Sex	Outcome	Treatment
1