BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE

    MDR report key: 12694198 · Received October 25, 2021

    Report

    Report Number
    3002682307-2021-00576
    Event Type
    Malfunction
    Date Received
    October 25, 2021
    Date of Event
    September 15, 2021
    Report Date
    November 2, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2103186. 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 BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE RETAINED SAMPLES, NO SIGNS OF DEFECT COULD BE IDENTIFIED. 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 BROKEN SYRINGES. WE BELIEVE THAT THE SYRINGE BARREL MOST LIKELY BROKE AS A CONSEQUENCE OF STRONG CONDITIONS DURING HANDLING OR TRANSPORT OF THE PRODUCT POST-PRODUCTION. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD¿ SYRINGE THERE WAS A DAMAGED/DEFORMED PRODUCT - DEVICE IS OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN OPENING THE PACKAGE A CRACK (3 CM) WAS FOUND AT THE SCALE PART OF THE BARREL."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD¿ SYRINGE THERE WAS A DAMAGED/DEFORMED PRODUCT - DEVICE IS OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN OPENING THE PACKAGE A CRACK (3 CM) WAS FOUND AT THE SCALE PART OF THE BARREL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588908 BD¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2103186

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown