BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSULIN SYRINGE 1CC 31G

    MDR report key: 5114482 · Received September 30, 2015

    Report

    Report Number
    1920898-2015-00003
    Event Type
    Injury
    Date Received
    September 30, 2015
    Date of Event
    September 5, 2015
    Report Date
    October 14, 2015
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: RESULT - A SAMPLE WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 4230854. CONCLUSIONS - AS THERE WAS NO ACTUAL RETURNED SAMPLE FOR INVESTIGATION, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. A SAMPLE WAS NOT RETURNED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    NO MEDICAL DEVICE EXPIRATION DATE. EVALUATION: A SAMPLE IS AVAILABLE FOR INVESTIGATION BUT HAS NOT BEEN RECEIVED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 4230854. AWAITING SAMPLE FROM CUSTOMER.

    Description of Event or Problem · 1

    PER REPORT, ON (B)(6) 2015 CUSTOMER WENT TO THE ER AFTER THE DEVICE NEEDLE BROKE OFF DURING INJECTION AND REMAINED IN HER BODY. SHE RECEIVED THREE X-RAYS. ALTHOUGH THEY SAW THE NEEDLE ON X-RAY, THEY WERE NOT ABLE TO RETRIEVE IT. ON (B)(6) 2015, THE CUSTOMER WENT TO THE SURGEON WHO ATTEMPTED TO RETRIEVE THE NEEDLE SURGICALLY BUT HE STATED IT WAS TOO DEEP IN THE MUSCLE. CUSTOMER RETURNED ON (B)(6) 2015 TO HAVE THE STITCHES REMOVED. CUSTOMER WAS COMPLETING HER COURSE OF ANTIBIOTICS AND NO INFECTION WAS NOTED DURING FOLLOW UP. THE CUSTOMER REPORTED THERE WILL BE NO FURTHER FOLLOW UP UNLESS THE SITE BECOMES INFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645828 BD INSULIN SYRINGE 1CC 31G INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 4230854

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention