BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEMOSAFELOCK BAG SPIKE

    MDR report key: 12406197 · Received September 1, 2021

    Report

    Report Number
    9617594-2021-00243
    Event Type
    Malfunction
    Date Received
    September 1, 2021
    Date of Event
    August 3, 2021
    Report Date
    August 4, 2021
    Product Code
    FPA
    UDI-DI
    00000000
    PMA / PMN Number
    K081361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE USED LIST #KL-BS001, CHEMOSAFELOCK BAG SPIKE; LOT #5103354 WAS RECEIVED FOR EVALUATION ON SEPTEMBER 8, 2021. THE SAMPLE HAD A HOLE IN THE CENTER OF THE OVER-MOLDED TIP OF THE CHEMOLOCK PORT SPIKE. NO DAMAGE OR ANOMALIES WERE OBSERVED. THE COMPLAINT WAS NOT CONFIRMED. THE LOT HISTORY WAS REVIEWED AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION. IT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A CHEMOSAFELOCK BAG SPIKE THAT THE CUSTOMER REPORTED THE AKPRA LEAKED FROM THE TOP OF THE CONNECTOR. A HOLE WAS CONFIRMED BY THE CUSTOMER ON THE TOP SURFACE OF THE BAG SPIKE. WHEN INSERTED INTO A SALINE BAG, LEAKAGE WAS CONFIRMED FROM THE TOP SURFACE OF THE BAG SPIKE, THIS WAS SIMULATED. THE EVENT OCCURRED AFTER STABBING AND WAS USED FOR INFUSION AND INJECTION PROCEDURES. THERE WAS A REPORT OF AN UNPROTECTED CHEMOTHERAPY EXPOSURE TO THE NURSE ON THE NURSE'S BODY. THE EXPOSED PORTION WAS RINSED OFF WITH WATER AND THE HEALTH CONDITION OF THE NURSE IS BEING MONITORED. THERE WAS NO MEDICAL INTERVENTION REPORTED. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORT OF HARM. THIS CAPTURES THE SECOND OF TWO EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308397 CHEMOSAFELOCK BAG SPIKE SET, ADMINISTRATION, INTRAVASCULAR FPA 5103354 00000000

    Patients

    Seq Age Sex Outcome Treatment
    1 AKPRA, MFR UNK