BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 13965178 · Received March 31, 2022

    Report

    Report Number
    3002682307-2022-00102
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Date of Event
    March 8, 2022
    Report Date
    May 17, 2022
    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

    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVALUTION?:YES. D.9. RETURNED TO MANUFACTURER ON: 30-MAR-2022 H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 300296 AND LOT NUMBER 2112225. 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, THE AFFECTED SAMPLE WAS RETURNED. THROUGH EXAMINATION OF THE SAMPLE, OUR QUALITY ENGINEER TEAM WAS ABLE TO CONFIRM THE REPORTED DEFECT OF TIP BREAKAGE. THE MATERIAL USED TO MANUFACTURE THE DISCARDIT SYRINGE 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 DEFECTIVE PRODUCT IDENTIFIED. AN EXACT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF THE BD DISCARDIT¿ II SYRINGE BROKE OFF ON THE AMPOULE OF PPI WATER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "THE TIP OF THE SYRINGE BROKE ON THE AMPOULE OF PPI WATER. NO CONSEQUENCE, NEW SYRINGE USED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF THE BD DISCARDIT¿ II SYRINGE BROKE OFF ON THE AMPOULE OF PPI WATER.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "THE TIP OF THE SYRINGE BROKE ON THE AMPOULE OF PPI WATER. NO CONSEQUENCE, NEW SYRINGE USED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107499 BD DISCARDIT¿ II SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2112225

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown