BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERIFIX

    MDR report key: 1070760 · Received July 1, 2008

    Report

    Report Number
    2523676-2008-00058
    Event Type
    Other
    Date Received
    July 1, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 17, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    CAZ
    PMA / PMN Number
    K840179
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DRUG AMPULES WERE NOT RETURNED TO THE MFR TO BE EVALUATED. WITHOUT THE ACTUAL SAMPLES A THOROUGH EVALUATION COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. ALL AVAILABLE INFO HAS BEEN FORWARDED TO THE DRUG MFR, HOSPIRA INC FOR FURTHER INVESTIGATION. IF ANY INFO IS REC'D FROM HOSPIRA INC. STATING THAT THERE IS AN INHERENT PROBLEM, THIS REPORT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    AS REPORTED PER THE USER FACILITY: WHEN OPENING TEST DOSE LIDOCAINE WITH EPINEPHRINE, THE VIAL SHATTERED IN THE RIGHT HAND, DESCRIBED AS "DISINTEGRATING" MANY PIECES OF GLASS SHARDS HAD TO BE REMOVED FROM THE HAND. LARGE PIECE OF GLASS REMOVED FROM THE THUMB, LACERATION ON THE THUMB AND INDEX FINGER. STERISTRIPS APPLIED, AND THE HAND WRAPPED. THE 2ND EPISODE OCCURRED TODAY AFTER THIS WITH ANOTHER CLINICIAN, THE VIAL "SHATTERED" DURING OPENING, WITHOUT INJURY. ADDITIONAL INFO WAS NOT PROVIDED BY THE FACILITY AFTER SEVERAL ATTEMPTS WERE MADE TO CONTACT THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIFIX CUSTOM EPIDURAL ANESTHESIA KIT CAZ B. BRAUN MEDICAL, INC. CESK 60986449

    Patients

    Seq Age Sex Outcome Treatment
    1 Other