BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 15910521 · Received December 2, 2022

    Report

    Report Number
    3002682307-2022-00322
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    November 9, 2022
    Report Date
    November 18, 2022
    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 IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. 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. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE PICTURE SAMPLE WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE, THE SYRINGE TIP WAS OBSERVED MISSING. AT THIS TIME, AN EXACT CAUSE CANNOT BE DETERMINED FOR THIS INCIDENT. THE MATERIAL USED TO MANUFACTURE THE DISCARDIT SYRINGES HAS BEEN SELECTED AND TESTED TO RESIST NORMAL CONDITIONS OF USE. THE ASSEMBLY MACHINES HAVE INLINE DETECTION SYSTEMS THAT INSPECT ALL PRODUCT AND AUTOMATICALLY REJECT ANY DEFECTIVE PRODUCT IDENTIFIED. WE BELIEVE THAT THIS INCIDENT MAY HAVE RESULTED FROM A BLOCKAGE IN THE BARREL FEEDING PROCESS. AFTER THAT, THE SYRINGE TIPS WERE DAMAGED AND WENT UNDETECTED BY THE ASSEMBLY MACHINE. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD DISCARDIT¿ II SYRINGE THE TIP OF THE SYRINGE BROKE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONE OF THE SYRINGE WAS MISSING,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2536263 BD DISCARDIT¿ II SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2031729

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown