FDA Adverse Event Malfunction Summary report: N

IVT DISPOSABLE

MDR report key: 3260323 · Received August 1, 2013

Report

Report Number: 1416980-2013-20423
Event Type: Malfunction
Date Received: August 1, 2013
Date of Event: July 9, 2013
Report Date: July 9, 2013
Manufacturer: BAXTER HEALTHCARE - AIBONITO
Product Code: KPE
PMA / PMN Number: K964853
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: PHARMACIST

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION SUMMARY: THE ACTUAL SAMPLE WAS AVAILABLE AT THE PLANT FOR EVALUATION. NO DEFECT WAS OBSERVED DURING VISUAL INSPECTION. A FUNCTIONAL FLOW RATE TEST WAS PERFORMED ON A SAMPLE FROM THE SAME LOT NUMBER BY FILLING THE CONTAINER WITH SOLUTION. CONTINUOUS FLOW OF THE SOLUTION WAS OBSERVED AND THE SAMPLE WAS FOUND TO BE WORKING WITHIN SPECIFICATION. THE REPORTED CONDITION WAS NOT CONFIRMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT AIR WAS OBSERVED IN A BAG OF GAMMA STERILIZED INTRAVIA EMPTY CONTAINER (250ML) WHEN IT WAS REMOVED FROM THE BOX. THIS WAS OBSERVED IN THE PHARMACY BEFORE USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE. THIS FILE REPRESENTS REPORT 16 OF 16.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
360444	IVT DISPOSABLE	CONTAINER, I.V.	KPE	BAXTER HEALTHCARE - AIBONITO		UR13D04090

Patients

Seq	Age	Sex	Outcome	Treatment
1