BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 14337726 · Received May 9, 2022

    Report

    Report Number
    3002682307-2022-00139
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Date of Event
    April 16, 2022
    Report Date
    July 11, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 309110 AND LOT NUMBER 2012501. 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, A PICTURE SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE, A CRACKED BARREL WAS OBSERVED. 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 SYRINGES OBSERVED. ALTHOUGH AN EXACT CAUSE CANNOT BE CONFIRMED, IT IS POSSIBLE THAT THIS INCIDENT RESULTED FROM A BLOCKAGE IN THE BARREL FEEDING PROCESS. THIS BLOCKAGE PRODUCED A DAMAGED SYRINGE, WHICH WENT UNDETECTED. 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 2 BD DISCARDIT¿ II SYRINGES HAD CRACKED BARRELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHLEBOTOMIST WAS COLLECTING BLOOD OF PATIENT AND SYRINGE BARREL WAS CRACKED".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD DISCARDIT¿ II SYRINGES HAD CRACKED BARRELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHLEBOTOMIST WAS COLLECTING BLOOD OF PATIENT AND SYRINGE BARREL WAS CRACKED"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565468 BD DISCARDIT¿ II SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2012501

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown