BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA

    MDR report key: 10909773 · Received November 26, 2020

    Report

    Report Number
    3002682307-2020-00381
    Event Type
    Malfunction
    Date Received
    November 26, 2020
    Date of Event
    August 1, 2020
    Report Date
    January 18, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 1904151. 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. A REVIEW WAS ALSO PERFORMED FOR THE MIXED PRODUCT LOT NUMBER 1904173 AND NO ISSUES WERE DETECTED DURING THE PRODUCTION FOR THIS LOT AS WELL. TO AID IN THE INVESTIGATION OF THIS ISSUE, PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE, A SHELF CARTON REFERENCING MATERIAL #301942 WAS FOUND TO CONTAIN A SYRINGE BELONGING TO MATERIAL # 309050. MATERIAL # 301942 AND LOT #1904151 WAS MANUFACTURED ON PRODUCTION LINE 2, WHILE MATERIAL # 309050 AND LOT # 1904173 WAS MANUFACTURED ON PRODUCTION LINE 1. THE SECONDARY PACKAGING MACHINES FOR THESE TWO LINES ARE MANAGED BY THE SAME MANUFACTURING OPERATOR. THIS INCIDENT MOST LIKELY RESULTED FROM THE OPERATOR ACCIDENTALLY INTRODUCING PRODUCT FROM ONE PRODUCTION LINE TO ANOTHER DURING THE PACKAGING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA CAME WITH A MIX OF PRODUCT TYPE. THIS OCCURRED ON 100 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2020, IT RECEIVED A 5ML SYRINGE MIXED WITH A BOX OF SYRINGE WHICH HAS NO NEEDLE.

    Additional Manufacturer Narrative · 1

    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 S2 5ML 22GA 1-1/4 IN BD (B)(6) CAME WITH A MIX OF PRODUCT TYPE. THIS OCCURRED ON 100 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2020, IT RECEIVED A 5ML SYRINGE MIXED WITH A BOX OF SYRINGE WHICH HAS NO NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1377735 SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1904151

    Patients

    Seq Age Sex Outcome Treatment
    1