BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML EMERALD BNS

    MDR report key: 8565160 · Received April 30, 2019

    Report

    Report Number
    3002682307-2019-00277
    Event Type
    Malfunction
    Date Received
    April 30, 2019
    Date of Event
    April 12, 2019
    Report Date
    May 22, 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
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAS BEEN PROVIDED WITH A PHOTO OF CATALOG 303127 LOT 9029551 TO INVESTIGATE FOR THIS RECORD. THE PHOTO SHOWS BD MANUFACTURED A N EMERALD 5ML SYRINGE WITH A PLUNGER OF DISCARDIT 5ML SYRINGE. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. ALTHOUGH BD HAS ESTABLISHED PROCEDURES AND VERIFICATION PROCESS FOR LINE-CLEARANCE; BD CAN CONCLUDE THAT ONE OF THOSE OPERATIONS FAILED. SPECIFICALLY, BD HAS CONFIRMED THAT THE MACHINE OPERATOR BY MISTAKE ACTIVATED THE AIRWAY SYSTEM USED TO FEED THE BD DISCARDIT PLUNGERS IN THE ASSEMBLY PROCESS. DESPITE THIS HUMAN ERROR, THIS SHOULD NOT HAVE ANY CONSEQUENCE ON THE PRODUCT BECAUSE THE BD DISCARDIT PLUNGER FEEDER IS EMPTIED WHEN MANUFACTURING BD EMERALD SYRINGES. THEREFORE, BD CAN CONCLUDE THIS ISSUE HAS BEEN ORIGINATED BECAUSE OF A COMBINATION OF BOTH SITUATIONS. A BHR WAS DONE FOR THE AFFECTED BATCH AND WAS CONFIRMED TO BE RELEASED ACCORDING TO DEFINED PROCEDURES AND REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DIFFERENT SYRINGES WERE FOUND WITH THE SYRINGES 5ML EMERALD BNS DURING THE PACKAGING PROCESS. THE CUSTOMER REPORTED 67733 OCCURRENCES OF THIS EVENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WOULD LIKE TO INFORM YOU ABOUT NEW NON-CONFORMANCE THAT WAS DETECTED AT THE BEGINNING OF THE PACKAGING PROCESS AT OUR SITE. INSIDE THE PACKAGE WITH SYRINGES P/N KZ-03127-001 (BD P/N 303127), LOT 71P19B0915 (BD BATCH 9029551) THERE WERE FOUND 2 PIECES OF DIFFERENT SYRINGE (PN UNKNOWN).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DIFFERENT SYRINGES WERE FOUND WITH THE SYRINGES 5ML EMERALD BNS DURING THE PACKAGING PROCESS. THE CUSTOMER REPORTED 67733 OCCURRENCES OF THIS EVENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WOULD LIKE TO INFORM YOU ABOUT NEW NON-CONFORMANCE THAT WAS DETECTED AT THE BEGINNING OF THE PACKAGING PROCESS AT OUR SITE. INSIDE THE PACKAGE WITH SYRINGES P/N KZ-03127-001 (BD P/N 303127), LOT 71P19B0915 (BD BATCH 9029551) THERE WERE FOUND 2 PIECES OF DIFFERENT SYRINGE (PN UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358660 SYRINGE 5ML EMERALD BNS SYRINGE FMF BECTON DICKINSON, S.A. 9029551

    Patients

    Seq Age Sex Outcome Treatment
    1 Other