BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 5329951 · Received December 28, 2015

    Report

    Report Number
    1920898-2015-00010
    Event Type
    Injury
    Date Received
    December 28, 2015
    Date of Event
    July 12, 2015
    Report Date
    February 18, 2016
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THE DATE OF EVENT REPORTED ON THE INITIAL MDR WAS ENTERED AS (B)(6) 2015. THE DATE OF EVENT SHOULD HAVE BEEN ENTERED AS (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, A NO SAMPLE INVESTIGATION WILL BE CONDUCTED AND UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 5082818. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. A SAMPLE IS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT APPROXIMATELY 7:00 AM ON (B)(6) 2015, AS A CONSUMER USED A BD ULTRA-FINE INSULIN SYRINGE TO INJECT NIATO MEDICATION INTO HIS PENIS PRIOR TO SEXUAL INTERCOURSE, THE NEEDLE BROKE OFF AND REMAINED IN THE CORPUS CAVERNOSUM OF HIS PENIS. THE PATIENT WENT TO A HOSPITAL AND WAS HOSPITALIZED FOR TWO DAYS. WHILE IN THE HOSPITAL HE RECEIVED TWO ULTRASOUNDS TO LOCATE THE BROKEN NEEDLE AND HAD SURGERY IN AN ATTEMPT TO REMOVE IT. THE SURGERY WAS UNSUCCESSFUL AS THE NEEDLE WAS TOO DEEP WITHIN THE CONSUMER'S PENIS AND THE DOCTOR FELT IT WAS TOO RISKY TO CONTINUE. ON (B)(6) 2015 THE PATIENT HAD A FOLLOW UP APPOINTMENT WITH A UROLOGIST. AS OF THE DATE OF THIS REPORT THE NEEDLE REMAINS INSIDE THE CONSUMER'S PENIS. THE CONSUMER ALSO REPORTED THAT HE IS CURRENTLY UNABLE TO HAVE SEXUAL INTERCOURSE AND THAT HE HAS BEEN TREATED WITH ANTIBIOTICS (CEPHALEXIN AND NEOMYCIN SULFATE BACITRACIN) AND PAIN MEDICATIONS (NIMESULINA AND DIPIRONE). AT PRESENT, THE CONSUMER STATES THAT HE IS NOT IN PAIN BUT THAT THE INCIDENT HAS CAUSED A "GREAT NUISANCE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854228 BD ULTRA-FINE¿ INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 5082818

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R