FDA Adverse Event Malfunction Summary report: N

ACCESS

MDR report key: 3092710 · Received May 3, 2013

Report

Report Number: 1416980-2013-11285
Event Type: Malfunction
Date Received: May 3, 2013
Date of Event: April 15, 2013
Report Date: April 15, 2013
Manufacturer: BAXTER HEALTHCARE - TURKEY
Product Code: FPA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TU
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). ADDITIONAL NARRATIVE: THE ACTUAL SAMPLE WAS DISCARDED. HOWEVER, ONE COMPANION SAMPLE AND ONE RETENTION SAMPLE WERE MADE AVAILABLE FOR EVALUATION. AS THE ACTUAL SAMPLE WAS DISCARDED, THE REPORTED CONDITION COULD NOT BE CONFIRMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED FOR THAT DEVICE. THE COMPANION SAMPLE AND RETENTION SAMPLE WERE EVALUATED. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED ON EACH DEVICE. THE DEVICES MET SPECIFICATION WITH REGARDS TO THE CUSTOMER REPORTED PROBLEM. THE CUSTOMER REPORTED PROBLEM WAS NOT CONFIRMED OR DUPLICATED DURING EVALUATION. THE ROOT CAUSE WAS NOT DETERMINED FOR THOSE DEVICES. A BATCH REVIEW WAS CONDUCTED AND REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. THERE WERE NO CHANGES TO SPECIFICATIONS, TEST METHODS, PROCESS, EQUIPMENT, OR RAW MATERIALS THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION.

Description of Event or Problem · 1

IT WAS REPORTED THAT A MEDISET'S ALUMINUM CLAMP WAS BROKEN. THIS EVENT OCCURRED BEFORE USE; HOWEVER, IT IS UNKNOWN IN WHICH CARE AREA THIS EVENT OCCURRED. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
194455	ACCESS	SET, ADMINISTRATION, INTRAVASCULAR	FPA	BAXTER HEALTHCARE - TURKEY		S1302702

Patients

Seq	Age	Sex	Outcome	Treatment
1