LIFESHIELD PRIMARY SET CLAVE Y-SITE 100

Report

Report Number: 9613251-2014-00121
Event Type: Malfunction
Date Received: July 21, 2014
Date of Event: June 27, 2014
Report Date: June 27, 2014
Manufacturer: HOSPIRA LTD.
Product Code: FPA
PMA / PMN Number: UNK
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. DURING THE INVESTIGATION, NO POSSIBLE CAUSES FOR THE CUSTOMER REPORTED LEAK WERE IDENTIFIED. 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. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FPA AND HAS A 510K OF K101677. THE INTERNATIONAL AFFILIATE WAS CONTACTED AND INFO ON REPROCESSING OF THE DEVICE WAS REQUESTED. NO RESPONSE HAS BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

Description of Event or Problem · 1

THE CUSTOMER CONTACT REPORTED A LEAK. AT AN UNSPECIFIED TIME, IT WAS REPORTED THAT AN UNSPECIFIED VOLUME OF NORMAL SALINE LEAKED FROM APPROX 2-3 INCHES FROM THE END OF THE IV LINE. THE CUSTOMER CONTACT INDICATED THAT IT WAS CLEAR TO STAFF THAT THE LEAK WAS NOT FROM THE CONNECTION SITE OR AT A Y-SITE. NO INFO WAS PROVIDED IF THE LEAK OCCURRED PRIOR TO OR DURING PT USE. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY IN THERAPY CRITICAL TO ANY PT. NO MEDICAL INTERVENTIONS WERE REPORTED. NO ADD'L INFO WAS PROVIDED INCLUDING IF THE TUBING SET WAS REPLACED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
425282	LIFESHIELD PRIMARY SET CLAVE Y-SITE 100	UNK	FPA	HOSPIRA LTD.	NA	352764W

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK