BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA-FINE¿ MINI PEN NEEDLE 5MM X 31G

    MDR report key: 5797071 · Received July 14, 2016

    Report

    Report Number
    9616656-2016-00042
    Event Type
    Injury
    Date Received
    July 14, 2016
    Date of Event
    June 29, 2016
    Report Date
    July 27, 2016
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K024109
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY THE MANUFACTURER IS USED. MEDICAL DEVICE EXPIRATION DATE: THIS DEVICE DOES NOT HAVE AN EXPIRATION DATE.

    Additional Manufacturer Narrative · 1

    RESULT - A SAMPLE WAS NOT RETURNED FOR EVALUATION. A LOT HISTORY REVIEW WAS CARRIED OUT FOR THE REPORTED LOT NUMBER 5161369. NO RELATED NON-CONFORMANCES WAS RAISED IN ASSOCIATION WITH THIS PACKAGED LOT, CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. CONCLUSIONS - AS THERE WAS NO ACTUAL RETURNED SAMPLE FOR EVALUATION, THE COMPLAINT COULD NOT BE CONFIRMED. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. POTENTIAL ROOT CAUSE IS RE-USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE OF THE SUSPECT DEVICE BROKE OFF IN THE ABDOMEN DURING AN INJECTION. THE CUSTOMER WENT TO THE EMERGENCY DEPARTMENT ON (B)(6) 2016 AND HAD AN X-RAY BUT THE NEEDLE WAS NOT SEEN AND NO ATTEMPTS WERE MADE TO RETRIEVE THE NEEDLE. THE FOLLOWING DAY, THE NEEDLE SURFACED AND THE CUSTOMER'S WIFE WAS ABLE TO REMOVE THE NEEDLE WITH TWEEZERS. THE CUSTOMER REPORTS HE IS OKAY "NOW JUST SORE FROM NEEDLE GETTING PUSS AT SITE". THE CUSTOMER REPORTS HE ROTATES INJECTION SITES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450224 BD ULTRA-FINE¿ MINI PEN NEEDLE 5MM X 31G INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 5161369

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention