FDA Adverse Event Malfunction Summary report: N

MEDIKIT SUPERCATH 5

MDR report key: 8296250 · Received January 31, 2019

Report

Report Number
8296250
Event Type
Malfunction
Date Received
January 31, 2019
Date of Event
December 6, 2018
Report Date
January 15, 2019
Manufacturer
ICU MEDICAL INC
Product Code
FOZ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA
Reporter Occupation
BIOMEDICAL ENGINEER

Narratives

Description of Event or Problem · 1

INFANT NEEDED A VENOUS BLOOD DRAW. PATIENT HAS A HISTORY OF BEING A DIFFICULT STICK SO BEDSIDE RN DECIDED TO USE IV CATHETER TO OBTAIN VENOUS BLOOD. ON SECOND ATTEMPT, A MEDIKIT SUPERCATH 5, 24 G, 3/4" IV CATHETER WAS USED. FLASHBACK WAS OBTAINED, RN RETRACTED NEEDLE AND PLACED SAFELY COVERED SHARP ON BED AS WE ATTEMPTED TO ASPIRATE BLOOD. ONCE WE REALIZED THE VEIN WAS NOT BLEEDING BACK, WE REMOVED THE HUB FROM THE VEIN. WE WENT TO PICK UP ALL THE TRASH (CHLORAPREP, IV PACKAGING, AND SHARP) IN THE BED AND REALIZED THE PLASTIC HOUSING THAT WAS SUPPOSED TO BE HOLDING THE RETRACTED SHARP FROM THE IV CATHETER COMPLETELY FELL APART. THERE WERE TWO PLASTIC PIECES AND THE SPRING; THE NEEDLE WAS NOWHERE TO BE FOUND. I AS WELL AS BEDSIDE RN CAREFULLY EXAMINED PATIENT AND ONCE FINDING NEEDLE WAS NOWHERE ON HER, GAVE HER TO MOB (MOTHER OF BABY) TO HOLD WHILE WE CAREFULLY REMOVED AND EXAMINED EVERY PIECE OF LINEN FROM BED. WE THEN LOOKED IN SHARPS CONTAINER TO SEE IF THE MISSING NEEDLE WAS THROWN AWAY WITH FIRST VENOUS BLOOD DRAW ATTEMPT SHARP; IT WAS NOT IN THERE. WE THEN FLASHED A FLASH LIGHT AND SEARCHED THE FLOOR AND CRIB CAREFULLY AND WERE UNABLE TO LOCATE THE MISSING NEEDLE. WE THEN STARTED TO CAREFULLY REMOVE EVERY ITEM UNDER THE CRIB (DIAPERS, WASH CLOTHES, DRY WIPES, ETC.) AND EVENTUALLY FOUND THE NEEDLE LOOSE AND COMPLETELY EXPOSED UNDER THE CRIB NEAR PATIENT'S DIAPERS AND BLUE CHUX UNDERPAD. ALL PARTS TO IV CATHETER INCLUDING PACKAGING (MINUS IV HUB WHERE FLASHBACK BLOOD WAS PRESENT AND DISCARDED IN SHARPS CONTAINER BEFORE REALIZING THE PLASTIC HOUSING HAD FALLEN APART) WERE COLLECTED, PLACED IN BIOHAZARD BAG, AND GIVEN THE MANAGERS. LOOSE NEEDLE WAS SECURED INTO ONE OF THE PLASTIC HOUSING PIECES TO PREVENT NEEDLE STICK INJURY. MANUFACTURER RESPONSE FOR SAFETY I.V. CATHETER, MEDIKIT SUPERCATH 5 (PER SITE REPORTER). ICU MEDICAL IS THE DISTRIBUTOR OF THIS DEVICE MANUFACTURED BY TOGO MEDIKIT CO, LTD OF (B)(6). THE ICU MEDICAL ACCOUNT REP INFORMED MEDICAL CENTER THAT ICU MEDICAL WILL MEET TO DISCUSS INCIDENT. SAMPLE PREPARED TO HAND OFF TO ICU MEDICAL REP.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
85233 MEDIKIT SUPERCATH 5 SAFETY I.V. CATHETER KIT FOZ ICU MEDICAL INC SP125-24-19Y 18D12KA

Patients

Seq Age Sex Outcome Treatment
1 79 DA