BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II SYRINGE W/O NEEDLE

    MDR report key: 9167156 · Received October 8, 2019

    Report

    Report Number
    3002682307-2019-00538
    Event Type
    Malfunction
    Date Received
    October 8, 2019
    Date of Event
    September 23, 2019
    Report Date
    November 27, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAS BEEN PROVIDED WITH PHOTOS FOR CATALOG 300296 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE PHOTOS IT WAS IDENTIFIED THAT THE IN ONE LOT OF DISCARDIT 20ML SYRINGES, BD INCLUDED BY ERROR A SHELF CARTON OF REFERENCE 301783 DISCARDIT 10ML. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. REVISION OF THE BATCH HISTORY RECORDS CONFIRMED THAT THE MIXED LOT OF DISCARDIT 10ML WAS MANUFACTURED IN PRODUCTION LINE 9. THIS PRODUCTION LINE IS ALLOCATED NEXT TO PRODUCTION LINE 10 WHERE DISCARDIT 20ML IS MANUFACTURED. THESE TWO SECONDARY PACKAGING MACHINES ARE MANAGED BY THE SAME OPERATOR. FOR THAT REASON, BD HAS CONCLUDED THAT THE REPORTED ISSUE OCCURRED DUE TO A FAILURE OF GOOD MANUFACTURING PRACTICES, THIS OPERATOR INTRODUCED SYRINGES OF LOT #1905182 IN A BOX OF 20ML LOT, PRODUCING THE REPORTED ISSUE. DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD DISCARDIT¿ II SYRINGE W/O NEEDLE HAS BEEN FOUND MIXED WITH OTHER PRODUCT BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: WE RECEIVED A CARDBOARD BOX OF THE BD PRODUCT 300296 BUT INSIDE, THERE WAS AT LEAST ONE BOX OF ANOTHER DEVICE, REF. 301783, LOT 1905182. WE DON'T HAVE ANYMORE THE CARDBOARD BOX SO I CAN'T TELL IF ALL THE CARDBOARD BOX IS AFFECTED OR IF THERE WAS ONLY ONE BOX. FOR NOW, WE GOT ONLY ONE COMPLAINT FOR ONE BOX.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD DISCARDIT¿ II SYRINGE W/O NEEDLE HAS BEEN FOUND MIXED WITH OTHER PRODUCT BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: WE RECEIVED A CARDBOARD BOX OF THE BD PRODUCT 300296 BUT INSIDE, THERE WAS AT LEAST ONE BOX OF ANOTHER DEVICE, REF. 301783, LOT 1905182. WE DON'T HAVE ANYMORE THE CARDBOARD BOX SO I CAN'T TELL IF ALL THE CARDBOARD BOX IS AFFECTED OR IF THERE WAS ONLY ONE BOX. FOR NOW, WE GOT ONLY ONE COMPLAINT FOR ONE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959440 BD DISCARDIT II SYRINGE W/O NEEDLE SYRINGE FMF BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other