BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML EMERALD BNS

    MDR report key: 11341318 · Received February 17, 2021

    Report

    Report Number
    3002682307-2021-00059
    Event Type
    Malfunction
    Date Received
    February 17, 2021
    Date of Event
    January 21, 2021
    Report Date
    February 23, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 0300735 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, IT WAS DETERMINED THAT THE MENTIONED PRODUCT MIX UP COULD NOT POSSIBLY RESULT FROM THE BD MANUFACTURING FACILITY. THE MANUFACTURING FACILITY DOES NOT PRODUCE ANY SYRINGES WITH A BLACK STOPPER. THE SYRINGE MIX UP MOST HAVE OCCURRED ELSEWHERE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 5ML EMERALD BNS CAME WITH A MIX OF PRODUCT TYPES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT 1 (PR#2317146): THE COMPLAINT IS REGARDING A MIX IN PRODUCTS FOUND IN OUR PRODUCTION CLEANROOM WITHIN REF (B)(4) (LL VERSION), FOUND MANY SYRINGES OF PROBABLY 303127 (LS VERSION) IMPACT LOT 0153258 OF REF (B)(4). COMPLAINT 2 (B)(6): WHEN WE RETRIEVE SAMPLING FOR THE SYRINGES WE NOTICED THAT THE REF (B)(4) (LS VERSION) LOT 0300735 HAD GREEN STOPPER SYRINGES. DURING THE MIX REF (B)(4) BLACK STOPPER SYRINGES WERE FOUND. WHEN RETRIEVING THE COMPONENT APPROVAL PICTURES WE SAW ALSO BLACK STOPPERS FOR THE REF (B)(4). (10450 IS OUR INTERNAL NUMBERING) IS ANYTHING CHANGED OVERTIME? GENERAL REMARK: IT COULD BE THAT THE SYRINGES IN THE MIX-UP WHERE NOT THE (B)(4) (LS VERSION) BUT LOOKED LIKE THIS REFERENCE. THEY HAVE FOUND THAT THE REFERENCE HAD THE LS VERSION AND NOT THE LL VERSION. UNFORTUNATELY NO SAMPLES WERE RETAINED OF THE MIX-UP.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 5ML EMERALD BNS CAME WITH A MIX OF PRODUCT TYPES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT 1 (PR# (B)(4)): THE COMPLAINT IS REGARDING A MIX IN PRODUCTS FOUND IN OUR PRODUCTION CLEANROOM WITHIN REF 301027 (LL VERSION), FOUND MANY SYRINGES OF PROBABLY 303127 (LS VERSION) IMPACT LOT 0153258 OF REF 301027. COMPLAINT 2 (PR# (B)(4)): WHEN WE RETRIEVE SAMPLING FOR THE SYRINGES WE NOTICED THAT THE REF 303127 (LS VERSION) LOT 0300735 HAD GREEN STOPPER SYRINGES. DURING THE MIX REF 303127 BLACK STOPPER SYRINGES WERE FOUND. WHEN RETRIEVING THE COMPONENT APPROVAL PICTURES WE SAW ALSO BLACK STOPPERS FOR THE REF 303127. (10450 IS OUR INTERNAL NUMBERING) IS ANYTHING CHANGED OVERTIME? GENERAL REMARK: IT COULD BE THAT THE SYRINGES IN THE MIX-UP WHERE NOT THE REF 303127 (LS VERSION) BUT LOOKED LIKE THIS REFERENCE. THEY HAVE FOUND THAT THE REFERENCE HAD THE LS VERSION AND NOT THE LL VERSION. UNFORTUNATELY NO SAMPLES WERE RETAINED OF THE MIX-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237550 SYRINGE 5ML EMERALD BNS SYRINGE FMF BECTON DICKINSON, S.A. 0300735

    Patients

    Seq Age Sex Outcome Treatment
    1