BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN 31G 8MM 5B 105BX DE

    MDR report key: 19724115 · Received July 11, 2024

    Report

    Report Number
    3023359743-2024-00283
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    June 17, 2024
    Report Date
    September 30, 2024
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    12 PEN NEEDLE UNITS IMPACTED BY THIS EVENT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN B4, G6, H2, H11 CORRECTION MADE TO H6 (TYPE OF INVESTIGATION, INVESTIGATION CONCLUSION) INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    PATIENT COMPLAINED ABOUT BENT PEN-NEEDLES. OTHER MEDICAL DEVICES/ACCESSORIES ASSOCIATED WITH THE MEDICAL DEVICE) BLOOD SUGAR DERAILMENT (HYPERGLYCEMIA) ON 3-4 DAYS ALWAYS 2 HOURS AFTER THE MEAL ALWAYS APPROX. 9 MMOL/DL MEASURED. THE PATIENT CONSUMES A DEFINED AMOUNT OF CARBOHYDRATE WITH EVERY MEAL (BEDRIDDEN AND CHRONIC WOUND HEALING DISORDERS) AND USUALLY ONLY APPROX. 6 MMOL/L, SO THE NEEDLE WAS SUSPECTED. THIS NEEDLE WAS NOT USED MORE THAN ONCE AND THEREFORE SHOWED NO REHOOKS OR SIMILAR. FURTHER NEEDLES FROM THE REMAINING CONTENTS OF THE PACK (30 NEEDLES) WERE SCREWED ONTO THE PEN AND INSULIN UNITS WERE SET. IN THE PROCESS 12 NEEDLES SHOWED NO CONTINUITY. EXCESS PRESSURE IN THE PEN WAS RELIEVED WITH A CONTINUOUS CANNULA. SAMPLE NO LONGER AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341124 PN 31G 8MM 5B 105BX DE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320524 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Other