BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 16398431 · Received February 17, 2023

    Report

    Report Number
    3002682307-2023-00026
    Event Type
    Malfunction
    Date Received
    February 17, 2023
    Date of Event
    January 26, 2023
    Report Date
    February 3, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER: 309050 AND LOT NUMBER: 2111221. 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 FURTHER EVALUATION; HOWEVER, NO SIGNS OF DEFECT WERE DETECTED IN THE RETAINED SAMPLES. AN EXACT CAUSE COULD NOT BE DETERMINED AT THIS TIME FOR THE REPORTED INCIDENT. 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 DEFECTIVE PRODUCT IDENTIFIED. BASED ON THESE PREVENTIVE MEASURES, WE BELIEVE THE SYRINGE COULD HAVE BEEN DAMAGED DURING A BLOCKAGE IN THE BARREL FEEDING PROCESS. THE SYRINGE DAMAGE COULD HAVE GONE UNDETECTED WITHIN THE ASSEMBLY MACHINE AND FINALLY RESULTED IN THE REPORTED DEFECT DURING USE. 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 THAT THE BD DISCARDIT¿ II SYRINGE CRACKED WHILE DRAWING UP MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "DURING THE WITHDRAWAL OF A DRUG, THE SYRINGE CRACKED AT THE LEVEL OF THE BODY ON APPROXIMATELY 5MM (IN THE LENGTH) WITHOUT SIGNIFICANT PRESSURE ON THE PISTON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119232 BD DISCARDIT¿ II SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2111221

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown