BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 2ML LS EMERALD

    MDR report key: 12206450 · Received July 21, 2021

    Report

    Report Number
    3002682307-2021-00338
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    June 23, 2021
    Report Date
    August 23, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2102233 AND THE MIXED IN LOT NUMBER 2102225. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. THROUGH REVIEW OF THE PRODUCTION RECORDS, IT WAS DISCOVERED THAT MATERIAL 307727, LOT NUMBER 2102233 WAS MANUFACTURED IN PRODUCTION LINE 12 WHILE PRODUCTION LINE 11 WAS MANUFACTURING THE 5ML EMERALD SYRINGES (MATERIAL 307731, LOT NUMBER 2102225). THE SECONDARY PACKAGING MACHINES WORK AUTOMATICALLY AND LOAD THE SHELF-CARTONS MECHANICALLY. EACH SHELF-CARTON HAS A DATAMATRIX CODE THAT CONTAINS ALL THE VARIABLE DATA FOR EACH BATCH. THE SECONDARY PACKAGING MACHINE HAS A DETECTION SYSTEM THAT READS THE DATAMATRIX CODE. THE DETECTION IS PERFORMED FOR THE SHELF-CARTON BEFORE IT IS PLACED WITHIN THE SHIPMENT BOX. BASED ON THIS DETECTION SYSTEM, IT IS NOT POSSIBLE THAT THIS INCIDENT RESULTED DURING A MIXTURE IN THE AUTOMATED PACKAGING PROCESS. IT IS POSSIBLE THAT THIS INCIDENT RESULTED DUE TO A HANDLING FAILURE AFTER PRODUCTION. THE SECONDARY PACKAGING MACHINES (PRODUCTION LINE 11 AND PRODUCTION LINE 12) ARE MANAGED BY THE SAME OPERATOR. IT IS POSSIBLE THAT THE OPERATOR INTRODUCED THE AFFECTED MIXED SHELF CARTON DURING PRODUCTION, RESULTING IN THE REPORTED ISSUE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE MIXED PRODUCT WITH BD SYRINGE 2ML LS EMERALD. 5ML SYRINGES WERE ALSO INCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "I AM ENCLOSING A COMPLAINT ABOUT SYRINGES DELIVERED FOR OUR PRODUCT LUPRON (2ML SYRINGES - ORDER NUMBER: (B)(4), BATCH NUMBER: 2102233). THERE WAS AN UNDER-MIX IN THE DELIVERY AND 100 SYRINGES WITH A VOLUME OF 5ML WERE ALSO FOUND. COULD YOU PLEASE CHECK WHAT COULD HAVE BEEN THE CAUSE OF THIS AND SEND US A DEVIATION REPORT BY 5 JULY?"

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2102233 AND THE MIXED IN LOT NUMBER 2102225. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. THROUGH REVIEW OF THE PRODUCTION RECORDS, IT WAS DISCOVERED THAT MATERIAL 307727, LOT NUMBER 2102233 WAS MANUFACTURED IN PRODUCTION LINE 12 WHILE PRODUCTION LINE 11 WAS MANUFACTURING THE 5ML EMERALD SYRINGES (MATERIAL 307731, LOT NUMBER 2102225). THESE TWO SECONDARY PACKAGING MACHINE LINES WERE MANAGED BY THE SAME OPERATOR. IT HAS BEEN CONCLUDED THAT AN ERROR OCCURRED, CAUSING THE OPERATOR TO INTRODUCE A SHELF CARTON FROM PRODUCTION LINE 11 INTO PRODUCTION LINE 12. THIS ERROR RESULTED IN THE REPORTED INCIDENT. BASED ON OUR STRICT PREVENTIVE MEASURES IN PLACE AND OUR EFFORTS ON IMPROVING OPERATOR QUALITY KNOWLEDGE, WE ARE CONFIDENT THIS HANDLING RELATED FAILURE WAS AN ISOLATED ISSUE WITH AN UNLIKELY CHANCE OF RECURRENCE. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE MIXED PRODUCT WITH BD SYRINGE 2ML LS EMERALD. 5ML SYRINGES WERE ALSO INCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "I AM ENCLOSING A COMPLAINT ABOUT SYRINGES DELIVERED FOR OUR PRODUCT LUPRON (2ML SYRINGES - ORDER NUMBER: 307727, BATCH NUMBER: 2102233). THERE WAS AN UNDER-MIX IN THE DELIVERY AND 100 SYRINGES WITH A VOLUME OF 5ML WERE ALSO FOUND. COULD YOU PLEASE CHECK WHAT COULD HAVE BEEN THE CAUSE OF THIS AND SEND US A DEVIATION REPORT BY 5 JULY?"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099756 BD SYRINGE 2ML LS EMERALD PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2102233

    Patients

    Seq Age Sex Outcome Treatment
    1