BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II SYRINGE

    MDR report key: 11244552 · Received January 28, 2021

    Report

    Report Number
    3002682307-2021-00028
    Event Type
    Malfunction
    Date Received
    January 28, 2021
    Date of Event
    August 10, 2020
    Report Date
    May 4, 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

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2003277. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECTS AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR THIS INCIDENT, TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY. THE RETAINED SAMPLES WERE EVALUATED; HOWEVER, NO SIGNS OF DEFECT WERE IDENTIFIED. THE MATERIAL USED TO MANUFACTURE THE DISCARDIT SYRINGES HAS BEEN SELECTED AND TESTED TO RESIST NORMAL CONDITIONS OF USE. THE ASSEMBLY MACHINES HAVE AN IN-LINE DETECTION SYSTEM THAT INSPECTS ALL PRODUCT AND AUTOMATICALLY REJECTS ANY PRODUCT WITH SIGNS OF DEFECT, SUCH AS BROKEN TIP. IT IS POSSIBLE THAT THE SYRINGE TIP BREAKAGE WAS A CONSEQUENCE OF STRONG CONDITIONS DURING USE. 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 TIP OF THE BD DISCARDIT¿ II SYRINGE BROKE OFF DURING THE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "THE TIP OF THE 10 ML SYRINGE SNAPPED OFF IN THE 4-WAY RAMP DURING THE IVL INJECTION OF EUPANTOL."

    Additional Manufacturer Narrative · 1

    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 TIP OF THE BD DISCARDIT¿ II SYRINGE BROKE OFF DURING THE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "THE TIP OF THE 10 ML SYRINGE SNAPPED OFF IN THE 4-WAY RAMP DURING THE IVL INJECTION OF EUPANTOL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141470 BD DISCARDIT II SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2003277

    Patients

    Seq Age Sex Outcome Treatment
    1