BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE¿ 10 ML LL BNS

    MDR report key: 16150655 · Received January 12, 2023

    Report

    Report Number
    1213809-2022-01378
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    December 22, 2022
    Report Date
    March 2, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 14-FEB-2023. H6: INVESTIGATION SUMMARY NINE SAMPLES AND TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED. TWO SAMPLES WERE OBSERVED TO HAVE MINOR COSMETIC SCUFFING INSIDE AND OUTSIDE OF THE PRINT AREA ON THE MID-POINT OF THE BARREL. ONE SAMPLE WAS OBSERVED TO HAVE A SNAPPED PLUNGER THUMB-REST. SIX SAMPLES WERE OBSERVED TO HAVE ONE VERTICAL CRACK EXTENDING UP THE BARREL. POTENTIAL ROOT CAUSE FOR THE CRACKED BARREL AND BROKEN THUMB-REST DEFECTS ARE ASSOCIATED WITH THE ASSEMBLY PROCESS. IT COULD BE POSSIBLE THAT AN INADVERTENT JAM OR IMPROPER TRANSFER BETWEEN ASSEMBLY DIALS LED TO THE CONDITION OBSERVED. THESE DEFECTS ARE OCCURRING AT AN EXPECTED RATE SO NO CORRECTIVE ACTIONS WILL BE MADE AT THIS TIME. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS 0071631, 0083097, 0127985 AND 0090399. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT#: 0071631, MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2025, DEVICE MANUFACTURE DATE: 11-MAR-2020, MEDICAL DEVICE LOT#: 0083097, MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2025, DEVICE MANUFACTURE DATE: 23-MAR-2020, MEDICAL DEVICE LOT#: 0127985, MEDICAL DEVICE EXPIRATION DATE: 30-APR-2025, DEVICE MANUFACTURE DATE: 06-MAY-2020, MEDICAL DEVICE LOT#: 0090399, MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2025, DEVICE MANUFACTURE DATE: 30-MAR-2020.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 320 OF THE BD SYRINGE¿ 10 ML LL BNS EXPERIENCED (SHORT DESCRIPTION OF EVENT) THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AS YOU CAN SEE BY THE PICTURES ATTACHED, SOME SYRINGES ARE CRACKED ON THE BODY (BARREL).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 320 OF THE BD SYRINGE¿ 10 ML LL BNS EXPERIENCED (SHORT DESCRIPTION OF EVENT). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AS YOU CAN SEE BY THE PICTURES ATTACHED, SOME SYRINGES ARE CRACKED ON THE BODY (BARREL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2074271 BD SYRINGE¿ 10 ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown