ACCESS

MDR report key: 4861904 · Received June 23, 2015

Report

Report Number: 1416980-2015-26212
Event Type: Malfunction
Date Received: June 23, 2015
Report Date: June 5, 2015
Manufacturer: BAXTER HEALTHCARE - AIBONITO
Product Code: FPA
PMA / PMN Number: K132734
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. A SYRINGE FILLED WITH WATER WAS ATTACHED TO THE ACTIVATED VALVE AND PRIMING WAS ATTEMPTED; HOWEVER, SOLUTION WOULD NOT FLOW THROUGH THE LINE. THE VALVE WAS REMOVED FROM THE SET AND THE SYRINGE WAS THEN ATTACHED TO THE FEMALE LUER; HOWEVER, SOLUTION STILL DID NOT FLOW. THERE WAS FOUND TO BE A SOLID BLOCKAGE INSIDE THE FEMALE LUER. THE CAUSE OF THE CONDITION WAS NOT DETERMINED. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. 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.

Description of Event or Problem · 1

IT WAS REPORTED THAT A CATHETER EXTENSION SET WITH ONE-LINK WOULD NOT PRIME. THE SET WAS BEING PRIMED WITH A SYRINGE PREFILLED WITH SALINE SOLUTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
406369	ACCESS	SET, ADMINISTRATION, INTRAVASCULAR	FPA	BAXTER HEALTHCARE - AIBONITO		UR15C08026

Patients

Seq	Age	Sex	Outcome	Treatment
1