FDA Adverse Event Malfunction Summary report: N

IVT DISPOSABLE

MDR report key: 2252662 · Received September 18, 2011

Report

Report Number: 6000001-2011-25635
Event Type: Malfunction
Date Received: September 18, 2011
Date of Event: August 23, 2011
Report Date: August 23, 2011
Manufacturer: BAXTER HEALTHCARE - SAO PAULO
Product Code: KPE
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE CUSTOMER RETURNED ONE COMPANION SAMPLE FOR EVALUATION. THE SAMPLE WAS FUNCTIONALLY TESTED AND THE REPORTED CONDITION WAS NOT CONFIRMED. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT AND NO DEVIATIONS WERE NOTED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

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 (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

Description of Event or Problem · 1

THE CUSTOMER REPORTED TO BAXTER (B)(4) REGARDING A BOLSA DE EVA 1000ML IN WHICH THE BAG LEAKED. AFTER FILLING THE BAG, AN INTEGRITY TEST WAS PERFORMED AND FOUND THAT THE BAG HAD LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT, THEREFORE, NO PATIENT INJURY OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 7 OF 10 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	IVT DISPOSABLE	CONTAINER, IV	KPE	BAXTER HEALTHCARE - SAO PAULO

Patients

Seq	Age	Sex	Outcome	Treatment
1