BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TYCO HEALTHCARE KENDALL

    MDR report key: 4466140 · Received January 24, 2015

    Report

    Report Number
    MW5040445
    Event Type
    Injury
    Date Received
    January 24, 2015
    Date of Event
    January 8, 2015
    Report Date
    January 23, 2015
    Manufacturer
    TYCO HEALTHCARE GROUP LP
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(6) WAS NOTIFIED. PT EVENT (B)(6) 2015. PT IN MENTAL HEALTH WAS BEING ADMINISTERED BI-WEEKLY 200MG DOSAGE HALDOL DECANOATE WHEN ATTENDING REGISTERED NURSE NOTICED MEDICATION LEAKING FROM THE NEEDLE WHERE NEEDLE ATTACHES TO THE SYRINGE. ATTENDING NURSE IMMEDIATELY PLACED THE SYRINGE DOWN AND NOTIFIED NURSE MANAGER. NURSE MANAGER DID HELP ASSESS EVENT. PHARMACY WAS CONTACTED AND PT PROVIDER NOTIFIED. A NEW AMPULE OF MEDICATION WAS ISSUED AND PICKED UP BY PHARMACY AND A NEW NEEDLE ATTACHED. PT WAS ADMINISTERED MEDICATION BY THE ATTENDING NURSE WITHOUT FURTHER CONSEQUENCE. (B)(4) WAS ASSIGNED DUTY TO PERFORM F/U REPORT FOR PT EVENT (B)(4) ON (B)(4) 2015. (B)(4) DID NOTIFY (B)(4). DEFECTIVE DEVICE HAS BEEN IDENTIFIED AS TYCO/KENDALL HEALTHCARE MONOJECT MAGELLAN SAFETY NEEDLE 22G X 1" WITH REFERENCE NUMBER (B)(4). ACTIONS TAKEN: MET WITH ATTENDING NURSE AND NURSE MANAGER INVOLVED THIS EVENT ON (B)(4) 2015; ATTENDING NURSE IDENTIFIED LEAKAGE POINT ON THE MEDICAL DEVICE DURING DEMONSTRATING PROCEDURE USED; LEAKAGE DID OCCUR AFTER USE FILTER NEEDLE AND REPLACEMENT FILTER NEEDLE WITH SAFETY NEEDLE THAT PROVED DEFECTIVE; DEFECTIVE SAFETY NEEDLE WAS DISCARDED BEFORE (B)(4) BECAME KNOWLEDGEABLE EVENT; HOWEVER, LIKELY LOT NUMBER 230356 EXPIRY 09-2017; (B)(4). REASON FOR USE: SCHIZOPHRENIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56927 TYCO HEALTHCARE KENDALL MONOJECT MAGELLAN SAFETY NEEDLE FMI TYCO HEALTHCARE GROUP LP SAFETY NEEDLE 22G X 1" 230356

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention HALDOL DECANOATE AMPULE 200MG BI-WEEKLY