FDA Adverse Event Malfunction Summary report: N

ACCESS

MDR report key: 2895503 · Received January 3, 2013

Report

Report Number: 1416980-2013-00191
Event Type: Malfunction
Date Received: January 3, 2013
Date of Event: December 12, 2012
Report Date: December 13, 2012
Manufacturer: BAXTER HEALTHCARE - SAO PAULO
Product Code: FPA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BR
Reporter Occupation: PHARMACIST

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION SUMMARY: ONE SAMPLE WITH THE ORIGINAL PACKAGING WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND BURNED MATERIAL (BLACK PARTICLE) WAS OBSERVED ON THE DRIP CHAMBER OF THE SET. THE REPORTED CONDITION WAS CONFIRMED. SINCE THE DRIP CHAMBER IS MANUFACTURED BY AN EXTERNAL SUPPLIER, THE REPORTED CONDITION IS ATTRIBUTED TO A SUPPLIER ISSUE. HOWEVER, THE EXACT ROOT CAUSE IS UNKNOWN. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

Description of Event or Problem · 1

A PHARMACIST REPORTED TO BAXTER (B)(4) A SOLUTION ADMINISTRATION SET IN WHICH THERE WAS "PRESENCE OF A "FOREIGN BODY" IN THE DRIP CHAMBER." THE EVENT OCCURRED BEFORE USE. THERE IS NO REPORT OF PATIENT INVOLVEMENT, INJURY/ADVERSE EVENTS, OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2115	ACCESS	SET, ADMINISTRATION, INTRAVASCULAR	FPA	BAXTER HEALTHCARE - SAO PAULO		PE40A0

Patients

Seq	Age	Sex	Outcome	Treatment
1