BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE STERILE

    MDR report key: 16433759 · Received February 24, 2023

    Report

    Report Number
    9614033-2023-00011
    Event Type
    Malfunction
    Date Received
    February 24, 2023
    Date of Event
    January 13, 2023
    Report Date
    June 6, 2023
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    00382903033102
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 07-MAR-2023 INVESTIGATION SUMMARY TWO SAMPLES AND PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, CRACKED BARREL ON SYRINGE IS OBSERVED, WHICH LIKELY CAUSED THE LEAKAGE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2221243 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE TEAMS INVESTIGATION, POSSIBLE ROOT CAUSE IS ASSOCIATED WITH MISALIGNMENT BETWEEN THE INPUT AND TRANSFER DISKS.

    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.

    Description of Event or Problem · 0

    MIT WAS REPORTED THAT 2 BD LUER-LOK¿ SYRINGE STERILE WAS DAMAGED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 22G IV PLACED IN PT'S AC. RN ATTACHED 20ML BD SYRINGE LOT #2221243 TO END OF IV CONNECTOR. WITHOUT PULLING BACK, BLOOD FLOWED FROM IV INTO SYRINGE AND THE SYRINGE CRACKED ALONG THE BARREL. RN TRIED A SECOND 20ML SYRINGE WITH THE SAME RESULT. OF NOTE, OTHER SYRINGES WITH THIS LOT NUMBER WERE USED ON THIS PATIENT WITH NO ISSUES. SYRINGES WERE SAVED AND WE WOULD LIKE TO SEND TO BD FOR EVALUATION AND REPORT.

    Description of Event or Problem · 0

    MIT WAS REPORTED THAT 2 BD LUER-LOK¿ SYRINGE STERILE WAS DAMAGED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 22G IV PLACED IN PT'S AC. RN ATTACHED 20ML BD SYRINGE LOT #2221243 TO END OF IV CONNECTOR. WITHOUT PULLING BACK, BLOOD FLOWED FROM IV INTO SYRINGE AND THE SYRINGE CRACKED ALONG THE BARREL. RN TRIED A SECOND 20ML SYRINGE WITH THE SAME RESULT. OF NOTE, OTHER SYRINGES WITH THIS LOT NUMBER WERE USED ON THIS PATIENT WITH NO ISSUES. SYRINGES WERE SAVED AND WE WOULD LIKE TO SEND TO BD FOR EVALUATION AND REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1934400 BD LUER-LOK¿ SYRINGE STERILE PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 2221243 00382903033102

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown