BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 26X1/2 RB

    MDR report key: 9281964 · Received November 5, 2019

    Report

    Report Number
    1911916-2019-01159
    Event Type
    Malfunction
    Date Received
    November 5, 2019
    Date of Event
    October 15, 2019
    Report Date
    December 3, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051114
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO WAS PROVIDED. IT SHOWS A NEEDLE ASSEMBLY CONNECTED TO A SYRINGE. THE NEEDLE ASSEMBLY HAS THE NEEDLE BENT AND GOES THROUGH THE PLASTIC SHIELD. IT IS LIKELY THAT THE NEEDLE WAS BENT DURING THE NEEDLE ASSEMBLY PROCESS AND WHEN THE SHIELD WAS PLACED, THE NEEDLE PIERCED THE SHIELD. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE 26X1/2 RB EXPERIENCED A BREACH IN STERILITY WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305111, BATCH NO: 9093862. DISTRIBUTOR REP CALLED TO REPORT THAT CUSTOMER RECEIVED PACKAGE AND WHEN THEY WENT TO PULL OUT STERILE PACKAGE, THE NEEDLE WAS THROUGH THE SIDE OF THE SHIELD CAUSING THE CUSTOMER TO STICK THEMSELVES WITH THE NEEDLE.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: (B)(6). 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 NEEDLE 26X1/2 RB EXPERIENCED A BREACH IN STERILITY WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305111 BATCH NO: 9093862. DISTRIBUTOR REP CALLED TO REPORT THAT CUSTOMER RECEIVED PACKAGE AND WHEN THEY WENT TO PULL OUT STERILE PACKAGE, THE NEEDLE WAS THROUGH THE SIDE OF THE SHIELD CAUSING THE CUSTOMER TO STICK THEMSELVES WITH THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070957 NEEDLE 26X1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 9093862 30382903051114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other