BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 16075258 · Received December 29, 2022

    Report

    Report Number
    3002682307-2022-00354
    Event Type
    Malfunction
    Date Received
    December 29, 2022
    Date of Event
    December 12, 2022
    Report Date
    February 7, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309210 AND LOT NUMBER 2031729. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY RETAINED SAMPLES WERE OBTAINED FOR EVALUATION; HOWEVER, NO SIGNS OF DEFECT WERE FOUND. ALTHOUGH WE WERE UNABLE TO CONFIRM THE REPORTED INCIDENT FOR THIS RECORD SPECIFICALLY, THIS TYPE OF DEFECT HAS BEEN PREVIOUSLY CONFIRMED FOR THIS LOT NUMBER BASED ON PREVIOUS SAMPLES RECEIVED. THE MATERIAL USED TO MANUFACTURE THE DISCARDIT SYRINGES HAS BEEN SELECTED AND TESTED TO RESIST NORMAL CONDITIONS OF USE. THE ASSEMBLY MACHINES HAVE AN INLINE DETECTION SYSTEM WHICH INSPECTS ALL PRODUCT AND AUTOMATICALLY REJECTS ANY DAMAGED PRODUCT IDENTIFIED. THIS INCIDENT MOST LIKELY RESULTED FROM A BLOCKAGE DURING THE BARREL FEEDING PROCESS. AFTER THE BLOCKAGE, THE TIP OF THE SYRINGE WAS DAMAGED AND WENT UNDETECTED WITHIN THE ASSEMBLY MACHINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP/LUER OF THE BD DISCARDIT¿ II SYRINGE HAD BROKEN OFF AND WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONE OF THE SYRINGE WAS MISSING."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP/LUER OF THE BD DISCARDIT¿ II SYRINGE HAD BROKEN OFF AND WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONE OF THE SYRINGE WAS MISSING,".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2767556 BD DISCARDIT¿ II SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2031729

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown