FDA Adverse Event Malfunction Summary report: N

ACCESS

MDR report key: 2902216 · Received January 8, 2013

Report

Report Number: 1416980-2013-00544
Event Type: Malfunction
Date Received: January 8, 2013
Date of Event: December 1, 2012
Report Date: December 14, 2012
Manufacturer: BAXTER HEALTHCARE - AIBONITO
Product Code: FPA
PMA / PMN Number: K112893
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE CAN NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

A SALES REP CALLED BAXTER CORPORATE PRODUCT SURVEILLANCE TO REPORT A CLEARLINK CATHETER EXTENSION SET IN WHICH THE TUBING RUPTURED. ACCORDING TO THE REPORT, THE FACILITY WAS USING THE EXTENSION SET IN CT WITH A POWER INJECTOR TO ADMINISTER CONTRAST TO THE PATIENT WHEN THE TUBING BURST APART. THE FACILITY IS AWARE THAT THESE SETS ARE NOT APPROVED TO BE USED WITH A POWER INJECTOR. THE EVENT OCCURRED DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
8807	ACCESS	SET, ADMINISTRATION, INTRAVASCULAR	FPA	BAXTER HEALTHCARE - AIBONITO

Patients

Seq	Age	Sex	Outcome	Treatment
1