FDA Adverse Event Malfunction Summary report: N

ACCESS

MDR report key: 3252826 · Received July 29, 2013

Report

Report Number: 1416980-2013-20050
Event Type: Malfunction
Date Received: July 29, 2013
Report Date: July 4, 2013
Manufacturer: BAXTER HEALTHCARE
Product Code: FPA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A BATCH REVIEW WILL BE CONDUCTED; SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED FROM THAT REVIEW; IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THE SAMPLE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE Y-PORT OF AN INTERLINK SYSTEM CONTINU-FLO SOLUTION SET WAS INACCESSIBLE WHEN USED WITH AN INTERLINK CONNECTOR. THE CUSTOMER STATED THAT THE CANNULA WOULD NOT PIERCE THE MEMBRANE. THIS ISSUE WAS DISCOVERED DURING INFUSION OF AN UNKNOWN DRUG. THE CUSTOMER STATED THAT THEY SET UP THE DEVICE WITH NEW SUPPLIES TO CONTINUE THERAPY. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
353658	ACCESS	SET, ADMINISTRATION, INTRAVASCULAR	FPA	BAXTER HEALTHCARE		R13B04169

Patients

Seq	Age	Sex	Outcome	Treatment
1