BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML LS 21X1-1/2 AN EMERALD

    MDR report key: 10925251 · Received December 1, 2020

    Report

    Report Number
    3002682307-2020-00384
    Event Type
    Malfunction
    Date Received
    December 1, 2020
    Date of Event
    November 6, 2020
    Report Date
    March 16, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR THE POTENTIAL LOT NUMBER CAPTURED WITHIN THE PROVIDED PICTURE, 1912136. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS INCIDENT, PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, ONE SHELF CARTON PRESENTED NO PRINTED INFORMATION AND ANOTHER SHELF CARTON HAD THE INFORMATION, BUT IT WAS DISPLACED. IT HAS BEEN DETERMINED THAT THIS INCIDENT RESULTED DURING THE LABEL PRINTING PROCESS. AFTER DISCUSSING THIS ISSUE WITH THE MANUFACTURING TECHNICIANS, IT WAS BEEN DETERMINED THAT A TEMPORARY PROBLEM IN THE PRINTING MACHINE OCCURRED AND LABELS WERE NOT PRINTED CORRECTLY NOR WERE THEY IDENTIFIED BY THE OPERATORS. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 5ML LS 21X1-1/2 AN EMERALD EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BECAUSE I HAVE THREE BOXES OF BD EMERALD 21G 40MM 5ML 10 6567682 SYRINGES FOR WHICH THERE IS A PRINTING DEFECT ON THE LABEL. TWO BOXES HAVE NO PRINTING AND THE THIRD ONE HAS A MISPRINT AND THEREFORE THE BATCH NUMBER AND EXPIRY DATE ARE NOT WRITTEN ON IT. ONE BOX IS PART OF OUR AGENCY STOCK AND TWO BOXES ARE FROM A CUSTOMER RETURN TO WHOM WE SOLD THEM.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 5ML LS 21X1-1/2 AN EMERALD EXPERIENCED NO LABEL, OR MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BECAUSE I HAVE THREE BOXES OF BD EMERALD 21G 40MM 5ML 10 6567682 SYRINGES FOR WHICH THERE IS A PRINTING DEFECT ON THE LABEL. TWO BOXES HAVE NO PRINTING AND THE THIRD ONE HAS A MISPRINT, AND THEREFORE, THE BATCH NUMBER AND EXPIRY DATE ARE NOT WRITTEN ON IT. ONE BOX IS PART OF OUR AGENCY STOCK AND TWO BOXES ARE FROM A CUSTOMER RETURN TO WHOM WE SOLD THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1392018 SYRINGE 5ML LS 21X1-1/2 AN EMERALD SYRINGE FMF BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1