BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 8654214 · Received May 30, 2019

    Report

    Report Number
    1911916-2019-00535
    Event Type
    Injury
    Date Received
    May 30, 2019
    Date of Event
    May 3, 2019
    Report Date
    May 21, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051091
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7200911, MEDICAL DEVICE EXPIRATION DATE: 2022-08-31, DEVICE MANUFACTURE DATE: 2017-07-19. MEDICAL DEVICE LOT #: 8090557, MEDICAL DEVICE EXPIRATION DATE: 2023-05-31, DEVICE MANUFACTURE DATE: 2018-03-31. INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF NEEDLE BROKEN FOR LOT #7200911 ITEM #305109. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION CONCLUSION AND WITHOUT A SAMPLE TO ANALYZE, THE CONDITION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED NOR COULD THIS SYMPTOM BE CORRELATED WITH A POTENTIAL CAUSE LINKED TO THE BD PROCESS. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION CONCLUSION AND WITHOUT A SAMPLE TO ANALYZE, THE CONDITION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED NOR COULD THIS SYMPTOM BE CORRELATED WITH A POTENTIAL CAUSE LINKED TO THE BD PROCESS. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE PROPOSED IN THE SCOPE OF THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT INJECTED HIMSELF IN THE PENIS WITH CAVERJECT BY USE OF THE BD PRECISIONGLIDE¿ NEEDLE, BUT UPON ATTEMPTING TO PLUNGE THE NEEDLE, IT BROKE OFF AND SPLIT INTO PIECES. AN ULTRASOUND WAS PERFORMED BY THE UROLOGIST AT THE HOSPITAL, WHERE THE PATIENT WAS INFORMED THAT REMOVING THE BROKEN NEEDLE PIECES WAS "DANGEROUS" AT THE TIME. AS SUCH, NO FOLLOWING PROCEDURES FOR NEEDLE REMOVAL HAVE BEEN REPORTED TO DATE. LOT #'S 7200911 AND 8090557 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACIST IS CALLING TO REPORT THAT A PATIENT OF HERS INJECTED HIMSELF WITH CAVERJECT IN THE PENIS. WHEN HE TRIED TO PLUNGE IN THE NEEDLE, IT WENT IN BUT THE NEEDLE BROKE OFF AND WAS SPLIT INTO PIECES. PATIENT WENT TO THE HOSPITAL AND UROLOGIST LOOKED AT IT WITH AN ULTRASOUND AND SAID IT WAS DANGEROUS TO REMOVE IT AND LEFT IT IN FOR NOW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449126 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE SECTION H.10. 30382903051091

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention