FDA Adverse Event Malfunction Summary report: N

ACCESS

MDR report key: 2253521 · Received September 19, 2011

Report

Report Number: 6000001-2011-25660
Event Type: Malfunction
Date Received: September 19, 2011
Date of Event: August 24, 2011
Report Date: August 25, 2011
Manufacturer: BAXTER HEALTHCARE - SHERBROOKE
Product Code: FPA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR THE SAMPLE IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (U.S.); THEREFORE, IT DOES NOT CONTAIN A U.S. 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S.

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

THE CUSTOMER REPORTED TO BAXTER (B)(4) ONE SECONDARY MEDICATION SET THAT BEGAN TO LEAK OUT. DURING PATIENT USE, THE TUBING PORTION THAT CONNECTS TO THE LUER-LOCK HAD SEPARATED OR COME APART AT THE COLLAR CONNECTION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. A SAMPLE IS AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACCESS	SET, ADMINISTRATION, INTRAVASCULAR	FPA	BAXTER HEALTHCARE - SHERBROOKE		1998407

Patients

Seq	Age	Sex	Outcome	Treatment
1