FDA Adverse Event Malfunction Summary report: N

BD INTROSYTE-N

MDR report key: 3896620 · Received June 11, 2014

Report

Report Number
3896620
Event Type
Malfunction
Date Received
June 11, 2014
Date of Event
June 10, 2014
Report Date
June 11, 2014
Manufacturer
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
Product Code
FOZ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MT, US

Narratives

Description of Event or Problem · 1

INFANT PATIENT: IN ATTEMPTING TO START A PICC LINE ON INFANT, INTRODUCER WAS INSERTED AND RECEIVED BLOOD RETURN. RETRACTED INTRODUCER NEEDLE, LEAVING THE INTRODUCER CATHETER ONLY. NURSE ATTEMPTED TO THREAD THE PICC LINE THROUGH THE INTRODUCER AND COULD NOT AFTER MULTIPLE ATTEMPTS. REMOVED INTRODUCER AND PICC LINE. ONCE THIS WAS OUT OF PATIENT THEY TRIED TO THREAD THE PICC THROUGH THE INTRODUCER AGAIN AND WERE STILL UNABLE TO DO SO WHILE BEING OBSERVED BY 2 TWO OTHER PHYSICIANS AND A NURSE. NURSE PULLED APART THE INTRODUCER (AS THEY ARE DESIGNED TO DO) TO CHECK FOR A CLOT OR OCCLUSION AND COULD NOT SEE ANY OBSTRUCTION. IN ATTEMPTING ANOTHER PICC BEFORE INSERTING THE INTRODUCER INTO THE SKIN THEY REMOVED THE NEEDLE FROM THE INTRODUCER FIRST AND SLID THE PICC THROUGH THE CATHETER TO CHECK THAT IT WAS CLEAR AND WERE ABLE TO (ALTHOUGH IT WAS A DIFFERENT LOT # OF INTRODUCER). NURSE WAS UNABLE TO HIT A VEIN PROPERLY WITH THIS INTRODUCER SO THEY TRIED AGAIN WITH ANOTHER. NURSE ATTEMPTED ANOTHER PICC AND AGAIN COULD NOT GET THE PICC LINE TO ADVANCE THROUGH THE INTRODUCER (ALTHOUGH NOT SURE THE INTRODUCER WAS IN THE VEIN PROPERLY IN ORDER TO START THE PICC). AGAIN PULLED THE PICC LINE OUT OF THE INTRODUCER AND TRIED TO ADVANCE THE PICC INTO THE INTRODUCER. THE PICC LINE WOULD, AGAIN, NOT ADVANCE THROUGH THE INTRODUCER. THIS INTRODUCER WAS LEFT INTACT THIS TIME FOR FURTHER EVALUATION. THEY DID REMOVE ANOTHER INTRODUCER FROM THE SUPPLY CABINET TO CHECK THE LOT AND THE PICC WOULD ADVANCE THROUGH THAT INTRODUCER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
344897 BD INTROSYTE-N CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT TERM FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. AUTOGUARD 26 GA 3274991

Patients

Seq Age Sex Outcome Treatment
1 2 MO