FDA Adverse Event Malfunction Summary report: N

INTROCAN SAFETY

MDR report key: 3022678 · Received March 11, 2013

Report

Report Number
3022678
Event Type
Malfunction
Date Received
March 11, 2013
Date of Event
March 5, 2013
Report Date
March 11, 2013
Manufacturer
B. BRAUN MEDICAL, INC.
Product Code
FOZ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
SC, US

Narratives

Description of Event or Problem · 1

THE NURSE WAS STUCK BY A SAFETY IV NEEDLE THAT DID NOT SHIELD ITSELF PROPERLY. THE NURSE WAS ATTEMPTING TO START AN IV LINE WHEN THE EVENT OCCURRED. THE NEEDLE POINT SLIPPED OUT THE SIDE OF THE SHIELDING CAP AND THE NURSE WAS STUCK BY THE DEVICE. THE NURSE SUFFERED A NEEDLESTICK TO THE FINGER AND HAD TO REPORT TO THE ED AS DO ALL OCCUPATIONAL EXPOSURES. LAB WORK WAS COMPLETED ON THE SOURCE PATIENT ONLY, WHO HARBORED NO BLOODBORNE PATHOGENS.THE NURSE RETRACTED THE NEEDLE AFTER SUCCESSFUL CANNULATION OF THE VEIN. THE TIP OF THE NEEDLE WAS NOT FULLY COVERED BY THE SHIELD AFTER RETRACTION. THE NURSE REPORTED THAT THE TIP OF THE NEEDLE WAS ACTUALLY STICKING OUT THROUGH THE SIDE OF THE DEVICE. THE RN DISPOSED OF THE DEVICE UNFORTUNATELY. HOWEVER, THE MANAGER SAT DOWN WITH THE NURSE AND WAS ABLE TO RECREATE THE EVENT WITH A STERILE VERSION OF THE SAME DEVICE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?START AN IV.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
102885 INTROCAN SAFETY CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 D FOZ B. BRAUN MEDICAL, INC. 4251652-02 2K0525A301

Patients

Seq Age Sex Outcome Treatment
1 *