FDA Adverse Event Malfunction Summary report: N

ACCESS

MDR report key: 2832047 · Received November 14, 2012

Report

Report Number: 1416980-2012-05093
Event Type: Malfunction
Date Received: November 14, 2012
Date of Event: October 23, 2012
Report Date: October 23, 2012
Manufacturer: BAXTER HEALTHCARE - MALTA
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 WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE CONDITION COULD NOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

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.

Description of Event or Problem · 1

PHARMACIST OF THE FACILITY REPORTED TO BAXTER (B)(6) OF A VENTED PACLITAXEL SET IN WHICH THE SALINE SOLUTION DID NOT PASS THROUGH THE SET'S FILTER. THE PHARMACIST ALSO INFORMED THAT THE SET PRESENTED NO FLOW AFTER THE FILTER. THE REPORTED CONDITION OCCURRED DURING PRIMING. 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
1	ACCESS	SET, ADMINISTRATION, INTRAVASCULAR	FPA	BAXTER HEALTHCARE - MALTA		11F26V747

Patients

Seq	Age	Sex	Outcome	Treatment
1