FDA Adverse Event Malfunction Summary report: N

ACCESS

MDR report key: 2944776 · Received February 5, 2013

Report

Report Number: 1416980-2013-03014
Event Type: Malfunction
Date Received: February 5, 2013
Date of Event: January 1, 2013
Report Date: January 30, 2013
Manufacturer: BAXTER HEALTHCARE - CLEVELAND
Product Code: NEP
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE USED IN THIS SITUATION IS 510(K) EXEMPT - CLASS II (SPECIAL CONTROLS); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. A BATCH REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

THE CUSTOMER REPORTED TO BAXTER HEALTHCARE CORPORATE PRODUCT SURVEILLANCE ONE (1) EXTENSION SET (WITH TWO MALE LUER LOCK ADAPTERS) IN WHICH LEAKING WAS DETECTED WHERE THE SET WAS CONNECTED TO AN UNKNOWN GLASS EVACUATED CONTAINER DURING A "BLOOD LETTING" PROCEDURE. THE CUSTOMER CHANGED THE EVACUATED CONTAINER AND LEAKING RECURRED WITH THE SAME EXTENSION SET. THE CUSTOMER THEN DISCONTINUED USE OF THE EXTENSION SET WITH EVACUATED CONTAINER AND USED A SYRINGE TO DRAW THE BLOOD FROM THE PATIENT'S ANGIOCATHETER WITHOUT FURTHER EVENT. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE IS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO FURTHER INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
48474	ACCESS	SYSTEM/DEVICE, PHARMACY COMPOUNDING	NEP	BAXTER HEALTHCARE - CLEVELAND

Patients

Seq	Age	Sex	Outcome	Treatment
1	84 YR			GLASS EVACUATED CONTAINER, ANGIOCATHETER