FDA Adverse Event Malfunction Summary report: N

ACCESS

MDR report key: 2832148 · Received November 14, 2012

Report

Report Number: 1416980-2012-05099
Event Type: Malfunction
Date Received: November 14, 2012
Date of Event: October 22, 2012
Report Date: October 22, 2012
Manufacturer: BAXTER HEALTHCARE - AIBONITO
Product Code: FPA
PMA / PMN Number: K112893
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). ADDITIONAL INFORMATION: THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION; HOWEVER A PHOTO OF THE DEFECTIVE SET WAS PROVIDED BY THE FACILITY. THE CUSTOMER REPORTED CONDITION WAS CONFIRMED THROUGH PHOTOGRAPHIC INSPECTION. THE ROOT CAUSE WAS NOT IDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

Description of Event or Problem · 1

A FACILITY CONTACTED BAXTER (B)(4) TECHNICAL SERVICES TO REPORT A CLEARLINK CATHETER EXTENSION SET WHERE "ONE OF THE EXTENSION SETS HAS BEEN PACKAGED INTO ANOTHER EXTENSION SET. IT APPEARS THAT DURING THE SEALING OF THE PACKAGING ONE OF THE EXTENSION SETS WAS OVERHANGING INTO THE OTHER AT THE TIME IT WAS BEING SEALED." THIS MALFUNCTION OCCURRED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT, NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACCESS	SET, ADMINISTRATION, INTRAVASCULAR	FPA	BAXTER HEALTHCARE - AIBONITO		UR12D24073

Patients

Seq	Age	Sex	Outcome	Treatment
1