BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD SAFETY-LOK INSULIN 1ML SYRINGES

    MDR report key: 6136126 · Received November 28, 2016

    Report

    Report Number
    MW5066422
    Event Type
    Other
    Date Received
    November 28, 2016
    Report Date
    September 1, 2016
    Manufacturer
    BD
    Product Code
    FMI
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ERROR DESCRIPTION, DESCRIPTION OF THE EVENT: THE FACILITY RECEIVED AN ORDER FOR BD SAFETY-LOK INSULIN 1ML SYRINGES. HOWEVER, THE PACKAGE CONTAINED 1 ML TB SYRINGES. INVESTIGATION RESULTS: AFTER REVIEW OF THE ABOVE ISSUES, THE FOLLOWING WAS DETERMINED. TYPE OF MEDICATION ERROR: INCORRECT PRODUCT, WAS THE MEDICATION ADMINISTERED TO THE RESIDENT: NO. AREA WHERE ERROR OCCURRED: DISPENSING AND FINAL REVIEW. MEDICATION(S)/PRODUCT(S) INVOLVED: BD SAFETY-LOK INSULIN 1 ML SYRINGE VS 1ML TB SYRINGES. ORDER ERROR POTENTIAL: LOW ROOT CAUSE: THE DISPENSING TECH DEVIATED FROM ESTABLISHED POLICY AND PROCEDURE AND DID NOT PROPERLY SCAN THE BAR CODE OF THE PRODUCT AGAINST THE BAR CODE IN THE PHARMACY SYSTEM. THE PHARMACIST DEVIATED FROM POLICY AND PROCEDURE AND DID NOT VERIFY THE MEDICATION IN THE CARD TO THE IMAGE ON THE COMPUTER SCREEN AND WHEN DIFFERENT, ASK TO SEE ORIGINAL BOTTLE. MEDICATION ADMINISTERED TO OR USED BY THE PT. NO. WHERE DID THE ERROR OCCUR: LONG TERM CARE PHARMACY. PT COUNSELING PROVIDED: UNK. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781551 BD SAFETY-LOK INSULIN 1ML SYRINGES BD SAFETY-LOK INSULIN 1ML SYRINGES FMI BD

    Patients

    Seq Age Sex Outcome Treatment
    1