PSI KIT: 8.5 FR X 4-1/8 (10 CM)

MDR report key: 2926588 · Received January 17, 2013

Report

Report Number: 2242445-2013-00008
Event Type: Malfunction
Date Received: January 17, 2013
Date of Event: January 10, 2013
Report Date: January 16, 2013
Manufacturer: ARROW INTL., INC.
Product Code: DYB
PMA / PMN Number: K780532
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem · 1

IT WAS REPORTED THAT IN THE OPERATING ROOM, DURING THE "FLOATING" OF THE SWAN GANZ CATHETER, A LEAK OCCURRED FROM THE PSI VALVE WITHIN FIVE SECONDS OF THE ANESTHETIST ADMINISTRATING PROPOFOL INTO THE PATIENT'S INTERNAL JUGULAR. DESPITE THE LEAK, THE CATHETER WAS NOT REPLACED BUT INSTEAD USED TO COMPLETE THE PROCEDURE. A DELAY WAS REPORTED, HOWEVER, THERE WAS NO HARM TO THE PATIENT DUE TO THIS DELAY OR AS A RESULT OF THIS OCCURRENCE. A TOTAL OF 5 OCCURRENCES WERE REPORTED. ALL COMPLAINTS INVOLVED ARE 2242445-2013-00005 THROUGH 2242445-2013-00009.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
26511	PSI KIT: 8.5 FR X 4-1/8 (10 CM)	CRITICAL CARE PSI PRODUCTS	DYB	ARROW INTL., INC.		NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK