FDA Adverse Event Malfunction Summary report: N

ACCESS

MDR report key: 2900441 · Received January 7, 2013

Report

Report Number: 1416980-2013-00462
Event Type: Malfunction
Date Received: January 7, 2013
Date of Event: December 1, 2012
Report Date: December 17, 2012
Manufacturer: BAXTER HEALTHCARE - MALTA
Product Code: FPA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION SUMMARY: ONE SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE ROLLER CLAMP WAS APPROXIMATELY AT THE MIDDLE OF THE TUBING IN A CLOSE POSITION. APPROXIMATELY 5 MM BELOW THE CHAMBER, A CUT WAS VISIBLE ON THE TUBE. THE REPORTED CONDITION WAS CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

THE CUSTOMER REPORTED TO BAXTER (B)(4) OF A FLO-GARD IV SOLUTION ADMIN SET IN WHICH "THE TUBING HAS SPLIT ABOUT 5MM UNDERNEATH THE CONNECTION BETWEEN THE CHAMBER AND THE TUBING. PRODUCT WAS BEING SET UP TO, HOWEVER HAD NOT YET BEEN CONNECTED TO PATIENT." THE EVENT OCCURRED DURING PRIMING. THERE IS NO REPORT OF PATIENT INVOLVEMENT, INJURY/ADVERSE EVENTS, OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
7029	ACCESS	SET, ADMINISTRATION, INTRAVASCULAR	FPA	BAXTER HEALTHCARE - MALTA		12K01V475

Patients

Seq	Age	Sex	Outcome	Treatment
1