BEUDAMED
    FDA Adverse Event Other Summary report: N

    PENCAN SPINAL NEEDLE TRAY

    MDR report key: 1187087 · Received October 2, 2008

    Report

    Report Number
    2523676-2008-00086
    Event Type
    Other
    Date Received
    October 2, 2008
    Report Date
    September 30, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    BSP
    PMA / PMN Number
    K932569
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DRUG SAMPLES WERE NOT RETURNED TO THE MANUFACTURER FOR EVAL. WITHOUT THE SAMPLES A THROUGH EVAL COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. ADDITIONAL PHONE CONVERSATION WITH THE REPORTER CONFIRMED THE FACILITY HAS HAD NO FURTHER PROBLEMS WITH TRAYS FROM THE SAME LOT OF PRODUCT. ALL AVAILABLE INFO HAS BEEN FORWARDED TO THE DRUG MANUFACTURER, HOSPIRA INC. FOR FURTHER INVESTIGATION. IF ANY INFO IS RECEIVED FROM HOSPIRA INC. STATING THAT THERE IS AN INHERENT PROBLEM, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: PT DEVELOPED SPINAL HEADACHE, TNS, & URINARY RETENTION. CUSTOMER USED 8 OTHER TRAYS FROM SAME CASE WITH NO FURTHER PROBLEM. ADDITIONAL INFO PROVIDED BY THE FACILITY TO B. BRAUN CLINICAL NURSE MANAGER INDICATED "IT WAS 5 PTS THAT EXPERIENCED SOME PROBLEMS POST SPINAL PROCEDURE: ONE PT HAD TNS. TWO PATIENTS HAD SPINAL HEADACHES. TWO PATIENTS HAD URINARY RETENTION. INCIDENTS OCCURRED APPROXIMATELY A MONTH AGO. PATIENTS' SYMPTOMS RESOLVED OVER TIME. DIFFERENT CLINICIANS WERE INVOLVED. PATIENTS WERE BOTH MALE AND FEMALE ORTHOPEDIC AND GENERAL SURGERY. (B) (6). ADDITIONAL INFO PROVIDED BY THE REPORTER INDICATED THAT ALL SYMPTOMS WERE TEMPORARY POST OPERATIVE AND NO ONE SUFFERED ANY ADDITIONAL ADVERSE SEQUELA ASSOCIATED WITH THE INCIDENTS REPORTED. THERE HAVE BEEN NO FURTHER PROBLEMS WITH THE SPINAL TRAYS TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENCAN SPINAL NEEDLE TRAY SPINAL NEEDLE TRAY BSP B. BRAUN MEDICAL, INC. 333852 60990935

    Patients

    Seq Age Sex Outcome Treatment
    1