BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATO/INFUSAID NEEDLE

    MDR report key: 102687 · Received July 2, 1997

    Report

    Report Number
    1219454-1997-00278
    Event Type
    Malfunction
    Date Received
    July 2, 1997
    Date of Event
    June 3, 1997
    Report Date
    June 3, 1997
    Manufacturer
    STRATO/INFUSAID, INC.
    Product Code
    FMI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED ON THIS CAT/LOT NUMBER AND NO MFG VARIANCES WERE IDENTIFIED IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS PERFORMED ON SIMILAR REPORTS INVOLVING THIS CAT/LOT NUMBER AND NO TRENDS HAVE BEEN IDENTIFIED. THE MFR'S INVESTIGATION OF THIS EVENT IS INCONCLUSIVE; HOWEVER, THE MFR IS IN THE PROCESS OF REINTRODUCING ANOTHER NEEDLE PRODUCT LINE BASED ON CUSTOMER PREFERENCE AND REQUESTS CONVEYED THROUGH THE MFR'S CUSTOMER SERVICE, COMPLAINTS DEPT, CLINICAL AND SALES REP. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    ON 06/03/1997, THE FACILITY NURSE CONTACTED THE MANUFACTURER AND REPORTED THAT, ON 06/03/1997, AN ATTEMPT WAS MADE TO ACCESS A DEVICE FOR REFILL WITH THE NEEDLE AND THE NEEDLE BENT IN THE PROCESS. THE USED NEEDLE WAS STATED TO HAVE BEEN DISCARDED; HOWEVER, THE REMAINING FOUR NEEDLES IN THE BOX ARE EXPECTED TO BE RETURNED FOR EVALUATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATO/INFUSAID NEEDLE NON-CORING HUBER POINT NEEDLE, STRAIGHT, 22GA X 1 1/2" FMI STRATO/INFUSAID, INC. NA 6K005M

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other