IVT DISPOSABLE

MDR report key: 3943427 · Received July 18, 2014

Report

Report Number: 1416980-2014-23185
Event Type: Malfunction
Date Received: July 18, 2014
Date of Event: June 24, 2014
Report Date: June 25, 2014
Manufacturer: BAXTER HEALTHCARE - MALTA
Product Code: KPE
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NZ
Reporter Occupation: PHARMACIST

Narratives

Additional Manufacturer Narrative · 1

(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THEREFORE, DEVICE ANALYSIS COULD NOT BE PERFORMED. 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). THIS WAS FOUND BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A DUAL CHAMBER EVA BAG WAS LEAKING FROM ITS PORT INTO THE SILVER OVERWRAP. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
422571	IVT DISPOSABLE	CONTAINER, I.V.	KPE	BAXTER HEALTHCARE - MALTA		13H01V539

Patients

Seq	Age	Sex	Outcome	Treatment
1