FDA Adverse Event Malfunction Summary report: N

IVT DISPOSABLE

MDR report key: 2760886 · Received September 26, 2012

Report

Report Number: 1416980-2012-00762
Event Type: Malfunction
Date Received: September 26, 2012
Date of Event: September 7, 2012
Report Date: September 7, 2012
Manufacturer: BAXTER HEALTHCARE - AIBONITO
Product Code: KPE
PMA / PMN Number: K090096
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TW
Reporter Occupation: PHARMACIST

Narratives

Additional Manufacturer Narrative · 1

(B)(4). DEVICE EVALUATION: 9 UNUSED SAMPLES WERE AVAILABLE FOR EVALUATION. A VISUAL INSPECTION REVEALED PARTICULATE MATTER INSIDE THE FLUID PATH OF THE BAG IN 2 OUT OF 9 RECEIVED BAGS. THE REPORTED CONDITION WAS NOT CONFIRMED IN THE SAMPLE ASSOCIATED WITH THIS REPORT. NO OTHER TESTS WERE PERFORMED. THE ASSIGNABLE ROOT CAUSE FOR THE REPORTED CONDITION IS UNKNOWN. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

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.

Description of Event or Problem · 1

THE FACILITY'S COMPOUNDING PHARMACIST REPORTED TO BAXTER (B)(4) THAT AN ALL-IN-ONE EMPTY CONTAINER HAD FOREIGN MATTER INSIDE THE BAG. THIS CONDITION WAS OBSERVED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. THERE IS NO ADDITIONAL INFORMATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	IVT DISPOSABLE	CONTAINER, I.V.	KPE	BAXTER HEALTHCARE - AIBONITO		UR09D07099

Patients

Seq	Age	Sex	Outcome	Treatment
1