BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA FINE NEEDLE

    MDR report key: 3037368 · Received March 26, 2013

    Report

    Report Number
    2243072-2013-00018
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 18, 2013
    Report Date
    March 26, 2013
    Manufacturer
    BD
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A BROKEN CANNULA. MICROSCOPIC EXAMINATION OF THE RETURNED SAMPLE REVEALED CHARACTERISTICS SUCH AS RESIDUAL BENDS ON THE BROKEN HUB END, CRACKED ADHESIVE, AND TUBING OVALITY (DEFORMATION FROM THE NORMALLY CIRCULAR CROSS SECTION). WHEN VIEWED TOGETHER, THESE ARE ALL INDICATORS OF BENDING/RE-STRAIGHTENING MODE OF FAILURE. REMOVAL OF SOME OF THE ADHESIVE MADE THIS OBSERVATION MORE APPARENT. THE SHIELD WAS ALSO EXAMINED FOR ANY POSSIBLE SCRAPES OR CUTS RELATED BY CANNULA RECAPPING OR IMPROPER SHIELDING, HOWEVER NOTHING WAS OBSERVED. ALTHOUGH BASED ON RECEIPT OF THIS COMPLAINT WE ACKNOWLEDGE THAT THE CUSTOMER HAS HAD AN ISSUE WITH THIS PARTICULAR PRODUCT, THIS COMPLAINT IS NOT CONFIRMED BASED ON THE RESULTS ACHIEVED FROM THE RETURNED SAMPLES. COMPLAINT HISTORY CHECK WAS PERFORMED AND AS OF ((B)(4) 2013) THIS IS THE 1ST COMPLAINT AGAINST LOT NUMBER 2171146 FOR SIMILAR ISSUES. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. THE DHR WAS ALSO RECEIVED FOR THE GIVEN LOT NUMBER AND NO NOTIFICATIONS WERE NOTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE CONSUMER HAD INJECTED 12 UNITS OF HUMALIN, WENT TO REMOVE THE NEEDLE AND THE NEEDLE WAS GONE. THE DAUGHTER TOOK HER TO THE EMERGENCY ROOM. THEY DID AN X-RAY AND DIDN'T' SEE ANYTHING. THEY THEN DID AN ULTRASOUND AND SAW THE NEEDLE. THE DOCTOR STATED THEY WERE GOING TO LEAVE THE NEEDLE ALONE BECAUSE IT WOULD DO MORE HARM THAN GOOD TO REMOVE THE NEEDLE. AT THE TIME OF THIS REPORT THE INJECTION SITE LOOKED GOOD AND THERE WAS NO SIGNS OF INFECTION OR IRRITATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123344 BD ULTRA FINE NEEDLE 31G ULTRA FINE II SHORT NEEDLE FMF BD 2171146C

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention