BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML E/T

    MDR report key: 8846027 · Received July 31, 2019

    Report

    Report Number
    3003152976-2019-00491
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Date of Event
    July 15, 2019
    Report Date
    September 6, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    30382903006138
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE SAMPLE WAS RETURNED TO OUR QUALITY ENGINEER FOR INVESTIGATION. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE STOPPER WAS INCORRECTLY ASSEMBLED TO THE PLUNGER, DISTORTED AGAINST THE BARREL WALL. A DEVICE HISTORY WAS PERFORMED AND FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED ISSUE DURING PRODUCTION OF BATCH 1902299. A VISION SYSTEM IS USED WITHIN THE ASSEMBLY MACHINE TO DETECT MISSING OR INCORRECTLY ASSEMBLED STOPPERS, REJECTING ANY DEFECTIVE PRODUCT. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THIS DEFECT LIKELY OCCURRED AS A RESULT OF IMPROPER ALIGNMENT OF THE PLUNGER/STOPPER TO THE BARREL DURING ASSEMBLY. A PROJECT HAS BEEN INITIATED TO LOOK FURTHER INTO THIS MALFUNCTION AND REDUCE ANY REOCCURRENCE. CORRECTIVE ACTION COR-537-19 IS OPENED TO INVESTIGATE AND REDUCE THE INCIDENT OF THIS DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED FOR FUTURE OCCURRENCE. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 20ML E/T EXPERIENCED A DEFECTIVE/DAMAGED STOPPER WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BLACK PART OF THE PLUNGER HAS A DEFORMATION.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 20ML E/T EXPERIENCED A DEFECTIVE/DAMAGED STOPPER WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BLACK PART OF THE PLUNGER HAS A DEFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638653 SYRINGE 20ML E/T PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1902299 30382903006138

    Patients

    Seq Age Sex Outcome Treatment
    1 Other