BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 50 ML LUER-LOK¿ SYRINGE

    MDR report key: 12849100 · Received November 19, 2021

    Report

    Report Number
    3003152976-2021-00772
    Event Type
    Malfunction
    Date Received
    November 19, 2021
    Date of Event
    October 22, 2021
    Report Date
    January 11, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLE OR PHOTOS RECEIVED FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2103099 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. RETAINED SAMPLES FROM THE SAME LOT WERE EVALUATED. A CLOSED PACK WAS VISUALLY INSPECTED AND THE CORRECT QUANTITY OF SYRINGES WERE FOUND IN THE PACK. PACKAGING FOR THIS REFERENCE IS A MANUAL WORK PER INTERNAL PROCEDURE, OPERATORS FILL THE TRAYS WITH THE SYRINGES. ALL TRAYS ARE WEIGHTED IN ORDER TO PROVE THE QUANTITY OF THE SYRINGES, IF WEIGHT IS INCORRECT, THE TRAY IS REFILLED BY THE OPERATOR. SECOND DEFECT REPORTED BY CUSTOMER IS LEAKAGE PAST THE STOPPER. LEAKAGE TEST WAS PERFORMED AND NO ISSUES OR LEAK OBSERVED. POSSIBLE ROOT CAUSE FOR SHORT COUNT IS ASSOCIATED WITH HUMAN ERROR. BASED ON THE INVESTIGATION RESULTS, NO MANUFACTURING RELATED DEFECTS COULD BE IDENTIFIED FOR LEAKAGE THEREFORE, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED BD (B)(6) ML LUER-LOK¿ SYRINGE HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONCE USING THIS SYRINGE TO PREPARE EPIDURAL MEDICATION IT ENDED UP LEAKING TO THE TABLE AND ONTO THE PHARMACISTS HANDS."

    Description of Event or Problem · 0

    IT WAS REPORTED BD PLASTIPAK¿ 50 ML LUER-LOK¿ SYRINGE HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONCE USING THIS SYRINGE TO PREPARE EPIDURAL MEDICATION IT ENDED UP LEAKING TO THE TABLE AND ONTO THE PHARMACISTS HANDS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1739303 BD PLASTIPAK¿ 50 ML LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2103099

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown