FDA Adverse Event Malfunction Summary report: N

GEM SPLT SET Y-EXT BCKCHK 282CM

MDR report key: 3969062 · Received July 23, 2014

Report

Report Number: 9615050-2014-04547
Event Type: Malfunction
Date Received: July 23, 2014
Date of Event: January 1, 2014
Report Date: July 3, 2014
Manufacturer: HOSPIRA COSTA RICA LTD.
Product Code: FRN
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BE
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER CONTACT INDICATED THAT THE DEVICES WERE 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 REPORTER WAS CONTACTED AND INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

Description of Event or Problem · 1

GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF DISCONNECTIONS. AT UNSPECIFIED TIMES, THE SECURE LOCK MALE ADAPTER OF THE TUBING SETS WERE CONNECTED TO UNSPECIFIED DEVICES AND WERE BEING USED TO DELIVER UNSPECIFIED MEDICATIONS. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THAT THE SECURE LOCK MALE ADAPTER OF THE TUBING SETS DISCONNECTED FROM THE PATIENTS. IT WAS REPORTED THAT REFLUXES OF BLOOD AT THE CATHETER LEVEL WERE NOTED. NO SPECIFIC DETAILS WERE PROVIDED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO DELAY IN THERAPIES CRITICAL TO ANY PATIENT. NO MEDICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
432103	GEM SPLT SET Y-EXT BCKCHK 282CM	UNK	FRN	HOSPIRA COSTA RICA LTD.		334665H

Patients

Seq	Age	Sex	Outcome	Treatment
1