FDA Adverse Event Malfunction Summary report: N

MICROBR GEMSTAR SPLIT SET 279CM (24EA/CS)

MDR report key: 3963227 · Received May 27, 2014

Report

Report Number: 9615050-2014-03643
Event Type: Malfunction
Date Received: May 27, 2014
Date of Event: April 17, 2014
Report Date: April 28, 2014
Manufacturer: HOSPIRA COSTA RICA LTD.
Product Code: FRN
PMA / PMN Number: K060806
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: PHARMACIST

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

Description of Event or Problem · 1

THE CUSTOMER CONTACT REPORTED A LEAK. THE SECURE LOCK MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO A HUBER NEEDLE CONNECTED TO THE PT'S IMPLANTABLE CATHETER AND WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF ETOPOPHOS, AT AN UNSPECIFIED RATE, VIA A GEMSTAR PUMP. AFTER 25 MINUTES, IT WAS REPORTED THAT A FEW MLS OF SOLUTION LEAKED AT THE REPORTED DISTAL LEVEL OF THE TUBING SET (COUPLING WITH A HUBER NEEDLE). IT WAS REPORTED THAT THE NURSE DISCONNECTED AND THEN RECONNECTED THE TUBING SET; HOWEVER, SOLUTION CONTINUED TO LEAK. NO SPECIFIC DETAILS WERE PROVIDED. THE CUSTOMER CONTACT REPORTED THAT THE SOLUTION THAT LEAKED WAS CLEANED UP PER THE USER FACILITY'S PROTOCOL. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO DELAY IN CRITICAL THERAPY TO THIS PT. NO MED INTERVENTIONS WERE REQUIRED. NO ADDITIONAL INFO WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
310314	MICROBR GEMSTAR SPLIT SET 279CM (24EA/CS)	80FRN	FRN	HOSPIRA COSTA RICA LTD.	NA	334035H

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK			UNSPECIFIED HUBER NEEDLE, MFR UNK