INTROCAN SAFETY

Report

Report Number: 9610825-2015-00202
Event Type: Malfunction
Date Received: May 28, 2015
Date of Event: November 8, 2014
Report Date: May 14, 2015
Manufacturer: B. BRAUN MELSUNGEN AG
Product Code: FOZ
PMA / PMN Number: K021094
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: RISK MANAGER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE ACTUAL DEVICE WAS NOT RETURNED FOR EVAL. WITHOUT THE ACTUAL SAMPLE, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED. THE BATCH MFG RECORD WAS REVIEWED AND THERE WERE NO SUCH DEFECT ENCOUNTERED DURING IN-PROCESS INSPECTION AND AT FINAL CONTROL INSPECTION. THE PROCESS CARDS SHOWED NO ABNORMALITIES. A HISTORICAL REVIEW OF THE COMPLAINT DATABASE IDENTIFIED NO ADVERSE TRENDS FOR PROD CODE 4552543-02 OR THE INVOLVED LOT. PER THE EVENT DESCRIPTION, IT WAS REPORTED THAT "WHEN THE USED SUPPLIES WERE BEING PICKED UP THE NURSE WAS STUCK BY THE USED NEEDLE". IT SHOULD BE NOTED THAT THE INTROCAN SAFETY IS DESIGNED TO REDUCE THE RISK OF NEEDLE STICK INJURIES. HOWEVER, CDC GUIDELINES AND/OR FACILITY PROTOCOLS SHOULD ALWAYS BE FOLLOWED. SHARPS SHOULD BE DISPOSED IF IMMEDIATELY INTO AN APPROPRIATE SHARPS CONTAINER. IF A SAMPLE AND/OR ADD'L PERTINENT INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

AS REPORTED BY THE USER FACILITY THROUGH MEDWATCH REPORT: "EVENT DESC: RN SUCCESSFULLY STARTED AN IV THEN PUSHED THE NEEDLE COVER TO SECURE DEVICE. WHEN THE USED SUPPLIES WERE BEING PICKED UP THE NURSE WAS STUCK BY THE USED NEEDLE. UPON INSPECTION IT APPEARED THAT THE NEEDLE COVER MALFUNCTIONED AND DIDN'T COVER THE SHARP. NO HARM TO THE PT. NURSE WAS EXPOSED TO PT'S BLOOD/BODY FLUIDS VIA UNINTENTIONAL NEEDLE STICK. (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
346292	INTROCAN SAFETY	IV SAFETY CATHETER	FOZ	B. BRAUN MELSUNGEN AG		14F26G8304

Patients

Seq	Age	Sex	Outcome	Treatment
1