FDA Adverse Event Malfunction Summary report: N

IVT DISPOSABLE

MDR report key: 2252539 · Received September 17, 2011

Report

Report Number: 6000001-2011-25556
Event Type: Malfunction
Date Received: September 17, 2011
Date of Event: August 1, 2011
Report Date: August 24, 2011
Manufacturer: BAXTER HEALTHCARE - MALTA
Product Code: KPE
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A CUSTOMER REPORTED TO BAXTER (B)(4) OF A 500ML EVA BAG IN WHICH DURING FILLING, THERE WERE PARTICLES IN THE BAG. THERE WAS NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION NECESSARY IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. HOWEVER, A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT AND NO DEVIATIONS WERE NOTED.

Additional Manufacturer Narrative · 1

(B)(4). A SAMPLE WAS REQUESTED FOR EVALUATION; HOWEVER, THE SAMPLE HAS NOT YET BEEN RECEIVED. SHOULD THE SAMPLE BE EVALUATED, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A 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

A CUSTOMER REPORTED TO BAXTER (B)(4) THAT PARTICLES WERE NOTED IN A 500ML EVA BAG DURING FILLING. THERE WAS NO PATIENT INVOLVEMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	IVT DISPOSABLE	CONTAINER, I.V.	KPE	BAXTER HEALTHCARE - MALTA		11B01V522M

Patients

Seq	Age	Sex	Outcome	Treatment
1