FDA Adverse Event Malfunction Summary report: N

GEM SPLT SET Y-EXT BCKCHK 282CM (50EA/CS)

MDR report key: 3969721 · Received May 6, 2014

Report

Report Number: 9615050-2014-03252
Event Type: Malfunction
Date Received: May 6, 2014
Date of Event: April 8, 2014
Report Date: April 8, 2014
Manufacturer: HOSPIRA COSTA RICA LTD.
Product Code: FRN
PMA / PMN Number: UNK
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: PHARMACIST

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT COMPLETE. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER LISTED IN THE "OTHER" FIELD. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FRN AND 510K OF K023062. THE INFO ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, 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 KINK. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF OLIMEL N7, AT AN UNSPECIFIED RATE, VIA A GEMSTAR PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE DISTAL END OF THE TUBING SET SOFTENED AND TWISTED THAT INDUCED AN OBSTRUCTION. NO SPECIFIC DETAILS WERE PROVIDED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAYS OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL DETAILS WERE PROVIDED INCLUDING IF NO FLOW OF SOLUTION WAS NOTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
271061	GEM SPLT SET Y-EXT BCKCHK 282CM (50EA/CS)	UNK	FRN	HOSPIRA COSTA RICA LTD.	NA	UNK5H

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK