BEUDAMED
    FDA Adverse Event Other Summary report: N

    RIGID INJECTION NEEDLE - STRAIGHT

    MDR report key: 992067 · Received February 5, 2008

    Report

    Report Number
    2135225-2008-00006
    Event Type
    Other
    Date Received
    February 5, 2008
    Date of Event
    January 23, 2008
    Report Date
    February 4, 2008
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    GAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE EVENT OCCURRED DURING PRIMING, OUTSIDE OF THE PATIENT, NO HARM WAS DONE TO THE PATIENT. THE DEVICE WAS DISPOSED OF SO THERE CAN BE NO EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED LOT, 1002944, MET ALL SPECIFICATIONS. IT WAS REPORTED THAT THE NEEDLE WAS BENT AT BOTH THE HUB AND TIP ENDS FOR USE. UPON REVIEW OF THE FDA MEDICAL DEVICE REPORT DECISION TREE AT BIOFORM MEDICAL INC., A DECISION WAS MADE TO REPORT THIS EVENT BASED ON THE CHANCE OF CAUSING INJURY IF THE EVENT WERE TO RECUR.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED DURING PRIMING, THE NEEDLE WAS BENT AT BOTH THE HUB AND TIP ENDS FOR USE, WHEN THE TIP BROKE OFF AT THE WELD. THE EVENT OCCURRED OUTSIDE THE PATIENT AND NO HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGID INJECTION NEEDLE - STRAIGHT INJECTION NEEDLE GAA BIOFORM MEDICAL, INC. 1002944

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other