BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD WALMART RELION INSULIN SYRINGE

    MDR report key: 5227342 · Received November 16, 2015

    Report

    Report Number
    1920898-2015-00005
    Event Type
    Injury
    Date Received
    November 16, 2015
    Date of Event
    October 29, 2015
    Report Date
    November 4, 2015
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K941657
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG #: OF NOTE, THE CATALOG NUMBER REPORTED BY THE CONSUMER WAS 311649. THIS CATALOG # IS FOR (B)(6) AND ITS COINCIDING BD CATALOG # IS 328507. SAMPLES, 2 USED LOOSE AND 80 UNUSED IN SEALED POLYBAGS, WERE RETURNED FOR EVALUATION. A VISUAL ANALYSIS OF THE USED UNITS REVEALED BROKEN CANNULAS. A MICROSCOPIC ANALYSIS OF THE USED UNITS REVEALED CHARACTERISTICS SUCH AS RESIDUAL BENDS ON THE BROKEN HUB END, CRACKED ADHESIVE, AND TUBING OVALITY (DEFORMATION FROM THE NORMALLY CIRCULAR CROSS SECTION). REMOVAL OF SOME OF THE EPOXY MADE THIS OBSERVATION MORE APPARENT. THIRTY OUT OF 80 SAMPLES IN THE SEALED POLY BAGS WERE ALSO EXAMINED AND NO BENT OR BROKEN CANNULA WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 5033899. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. HOWEVER, OUR QUALITY ENGINEER NOTES THAT WHEN VIEWED TOGETHER, ALL OF THE INVESTIGATION FINDINGS ARE INDICATORS OF BENDING/RE-STRAIGHTENING MODE OF FAILURE. DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CONSUMER HAD TWO BD (B)(6) RELION INSULIN SYRINGE NEEDLES BREAK OFF IN HER ABDOMEN WHILE SHE WAS INJECTING HERSELF. THE CONSUMER WENT TO AN EMERGENCY DEPARTMENT TO BE EVALUATED AND RECEIVED AN X-RAY. THE X-RAY DID NOT VISUALIZE THE NEEDLES AND SHE REPORTED THAT SHE WAS ADVISED TO WAIT AND SEE IF THE INJECTION SITE BECOMES INFECTED. NO FURTHER MEDICAL INTERVENTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755756 BD WALMART RELION INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 5033899

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention