BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCUCUT BONE BIOPSY NEEDLE (17GA. X10CM.)

    MDR report key: 125508 · Received September 12, 1997

    Report

    Report Number
    2411512-1997-00005
    Event Type
    Injury
    Date Received
    September 12, 1997
    Date of Event
    August 18, 1997
    Report Date
    August 18, 1997
    Manufacturer
    ANGIOMED
    Product Code
    KNW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    E-Z-EM, INC HAD PROVIDED THE CUSTOMER WITH A RETURN AUTHORIZATION # FOR RETURN OF A PRODUCT SAMPLE ON 8/19/97. AS OF 10/13/97, NO PRODUCT HAS BEEN REC'D AND E-Z-EM HAS BEEN UNSUCCESSFUL IN ATTAINING ANY ADD'L INFO FROM THE CUSTOMER. (CUSTOMER WAS LEFT TWO MESSAGES VIA PHONE, AND A LETTER WAS SENT ON 9/12/97). WITHOUT A PRODUCT SAMPLE, THE EXACT CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED. HOWEVER, A REVIEW OF THE MFG AND INSPECTION RECORDS FOR THE PRODUCT LOT IN QUESTION REVEALED THE PRODUCT TO MEET ALL REQUIRED SPECS PRIOR TO SHIPMENT. IT IS THE OPINION OF E-Z-EM'S MED DIR THAT ALTHOUGH THIS TYPE OF INCIDENT IS RARE, IT CAN OCCUR INFREQUENTLY DUE TO THE AMOUNT OF TORQUE NEEDED TO DO A BONE BIOPSY. IF A PRODUCT SAMPLE IS REC'D BY E-Z-EM, INC THE COMPLAINT FILE WILL BE REOPENED AND FURTHER ANALYSIS OF THE SAMPLE WILL BE PERFORMED. IF NOT, THIS WILL BE THE FINAL FILING SUBMITTED TO THE FDA FOR THIS EVENT. COMPLAINT CODE #'S 1104 AND 1415-NOT LABELED.

    Description of Event or Problem · 1

    DURING BIOPSY PROCEDURE, THE LUER LOCK CAME OFF THE NEEDLE IN THE PT'S VERTEBRA. THE DR WAS ABLE TO RETRIEVE THE LUER LOCK USING SURGICAL INSTRUMENTS. PT WAS NOT ADMITTED AND APPEARED TO BE DOING OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUCUT BONE BIOPSY NEEDLE (17GA. X10CM.) BONE BIOPSY NEEDLE KNW ANGIOMED NA 9258NF

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other