BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD PEN NEEDLE

    MDR report key: 12276755 · Received August 4, 2021

    Report

    Report Number
    2243072-2021-02016
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    June 27, 2021
    Report Date
    July 30, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. 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. INVESTIGATION CONCLUSION: CAN¿T PERFORM DHR AND MANUFACTURE RECORDS REVIEW, DUE TO BATCH NO. 0181156 IS NOT FOUND IN MANUFACTURE SITE. BD USED CANNULAS WAS EVALUATED FOR BIOLOGICAL COMPATIBILITY AND MET REQUIREMENT TO BE SAFE FOR THE INTENDED USE DURING DESIGN PHASE. NO RETURNED SAMPLES OR ACTUAL DEFECT SAMPLES FOR INVESTIGATION, SO WE CAN¿T PERFORMING IN-DEPTH INVESTIGATION. PEN NEEDLE PRODUCT HAS 100% IV POINT INSPECTION BY VISUAL SYSTEM, AND DEFECT PART WILL BE REJECTED AUTOMATICALLY. BASE ON INVESTIGATION ABOVE, THE CERTAIN CAUSE CAN¿T BE CONCLUDED AT THE MOMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD PEN NEEDLE EXPERIENCED A PEN NEEDLE THAT WOULD NOT DETACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE PATIENT WAS INJECTED WITH INSULIN, IT WAS DIFFICULT TO REMOVE THE NEEDLE ON THE DISPOSABLE INJECTION PEN, WHICH CAUSED SLIGHT PAIN AND INJURY TO THE PATIENT'S SKIN. THE NURSE IMMEDIATELY REMOVED THE NEEDLE WITH A TOOL, AND THE PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172036 UNSPECIFIED BD PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1