FDA Adverse Event Malfunction Summary report: N

ACCESS

MDR report key: 2855026 · Received December 3, 2012

Report

Report Number: 1416980-2012-06351
Event Type: Malfunction
Date Received: December 3, 2012
Date of Event: November 9, 2012
Report Date: November 9, 2012
Manufacturer: BAXTER HEALTHCARE - MALTA
Product Code: FPA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: HK
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION SUMMARY: ONE SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE TUBING HAD A DENT 2.5 CM BELOW THE CHAMBER. THE REPORTED CONDITION WAS CONFIRMED. THE MOST PROBABLE ROOT CAUSE OF THE DENT MAY BE DUE TO THE ASSEMBLING MACHINE WHERE THE TUBE AND CHAMBER WAS ASSEMBLED. ADDITIONAL INFORMATION: 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 A CAPA. 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. 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

THE CUSTOMER REPORTED TO BAXTER (B)(4) A FLO-GARD IV. SOLUTION ADMIN.SET IN WHICH THERE ARE BLOCKAGES THROUGHOUT THE TUBING. A PATIENT WAS INVOLVED, BUT THERE WAS NO REPORT OF PATIENT/USER INJURY NOR MEDICAL INTERVENTION NEEDED 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		11G31V158

Patients

Seq	Age	Sex	Outcome	Treatment
1