FDA Adverse Event Malfunction Summary report: N

NDEHP PRIMARY PLUM CLAVE Y

MDR report key: 1800009 · Received August 12, 2010

Report

Report Number: 9615050-2010-00152
Event Type: Malfunction
Date Received: August 12, 2010
Date of Event: July 13, 2010
Report Date: July 15, 2010
Manufacturer: HOSPIRA COSTA RICA LTD.
Product Code: FPA
PMA / PMN Number: UNK
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

DUE TO HAZARDOUS CONTAMINATION, THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER 12030. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FRN AND HAS A 510K OF K865060. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

Description of Event or Problem · 1

THE CUSTOMER CONTACT REPORTED DEVICE BREAKAGE; SUBSEQUENTLY A LEAK OF A CHEMOTHERAPEUTIC AGENT WAS NOTED. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CHEMOTHERAPEUTIC AGENT. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, IT WAS REPORTED THAT THE TUBING SET LEAKED FROM THE SECONDARY CLAVE PORT. THE VOLUME OF SOLUTION THAT LEAKED WAS NOT SPECIFIED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REPORTED. MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NDEHP PRIMARY PLUM CLAVE Y	UNK	FPA	HOSPIRA COSTA RICA LTD.	NA	830775H

Patients

Seq	Age	Sex	Outcome	Treatment
1