BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP

    MDR report key: 9070188 · Received September 16, 2019

    Report

    Report Number
    1213809-2019-00931
    Event Type
    Malfunction
    Date Received
    September 16, 2019
    Date of Event
    August 29, 2019
    Report Date
    October 25, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096498
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: FOUR 5ML SYRINGES WERE RECEIVED AND EVALUATED. TWO WERE LOOSE AND TWO WERE IN FULLY SEALED BLISTER PACKS FROM BATCH 8092982 (P/N 309649). ALL THE SYRINGES WERE OBSERVED TO HAVE TO NORMAL AND EXPECTED AMOUNT OF SILICONE PER PRODUCT SPECIFICATION. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE SECTION H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT EXCESS SILICONE WAS FOUND IN THE BD SYRINGE LUER-LOK¿ TIP PISTON BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TO MUCH SILICONE OIL IN PISTON"

    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 THAT EXCESS SILICONE WAS FOUND IN THE BD SYRINGE LUER-LOK¿ TIP PISTON BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TOO MUCH SILICONE OIL IN PISTON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866525 BD SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8092982 30382903096498

    Patients

    Seq Age Sex Outcome Treatment
    1 Other