BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 20 ML SYRINGE W/ NEEDLE

    MDR report key: 8956817 · Received September 3, 2019

    Report

    Report Number
    3002682307-2019-00477
    Event Type
    Malfunction
    Date Received
    September 3, 2019
    Date of Event
    August 16, 2019
    Report Date
    September 27, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAS BEEN PROVIDED WITH A PHOTO FOR CATALOG: 301948, LOT: 1811364 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE PHOTO SHOWED A BLACK AND YELLOW PARTICLE IN THE BODY OF THE SYRINGE, OUTSIDE THE FLUID PATH. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. BD HAS DETERMINED THAT THE FOREIGN MATTER OF THE NON-CONFORMANCE CONSISTS OF DUST PARTICLES MIXED WITH THE SILICONE OF THE SYRINGE. THE SILICONE OIL IS USED TO LUBRICATE THE INNER PART OF THE BARREL AND FACILITATE THE MOVEMENT OF THE PLUNGER ROD. THE DUST IN THIS CASE CAME FROM THE HOPPER OF THE ASSEMBLY MACHINE. IN THAT CASE, BD CONSIDERS THAT BECAUSE OF A PUNCTUAL FAILURE IN THE CLEANING PROCEDURES BY THE OPERATOR, THE PRESENCE OF THIS PARTICULATES IN THE HOPPER WAS NOT CORRECTLY AVOIDED MANUFACTURING. DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ 20 ML SYRINGE W/ NEEDLE HAD MOLD INSIDE THE BARREL. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2019, RECEIVED A COMPLAINT FROM A NURSING DEPARTMENT. THE SYRINGE WAS FOUND TO HAVE MILDEW ON THE INSIDE OF BARREL.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ 20 ML SYRINGE W/ NEEDLE HAD MOLD INSIDE THE BARREL. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6), 2019, RECEIVED A COMPLAINT FROM A NURSING DEPARTMENT. THE SYRINGE WAS FOUND TO HAVE MILDEW ON THE INSIDE OF BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748594 BD 20 ML SYRINGE W/ NEEDLE SYRINGE FMF BECTON DICKINSON, S.A. 1811364

    Patients

    Seq Age Sex Outcome Treatment
    1 Other