BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD NEOFLON¿ IV CANNULA

    MDR report key: 7692843 · Received July 16, 2018

    Report

    Report Number
    9616656-2018-00135
    Event Type
    Injury
    Date Received
    July 16, 2018
    Date of Event
    June 22, 2018
    Report Date
    August 14, 2018
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FOZ
    UDI-DI
    10885403811012
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: SEX: FEMALE. EVENT ATTRIBUTED TO: REQUIRED INTERVENTION. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURER: NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD ULTRA FINE¿ INSULIN PEN NEEDLE DETACHED DURING USE, AND REMAINED IN THE PATIENT AT THE INJECTION SITE. THE CONSUMER VISITED A DOCTOR WHOM ADVISED TO SEEK TREATMENT IN THE ER. AN X-RAY WAS OBTAINED AND THE NEEDLE WAS NOT DETECTED.

    Additional Manufacturer Narrative · 1

    NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. SEVERITY: OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE BREAKS OFF DURING USE ON LOT # 7200551. BASED ON THE SAMPLES/PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. 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.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. . A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD ULTRA FINE INSULIN PEN NEEDLE DETACHED DURING USE, AND REMAINED IN THE PATIENT AT THE INJECTION SITE. THE CONSUMER VISITED A DOCTOR WHOM ADVISED TO SEEK TREATMENT IN THE ER. AN X-RAY WAS OBTAINED AND THE NEEDLE WAS NOT DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD ULTRA FINE¿ INSULIN PEN NEEDLE DETACHED DURING USE, AND REMAINED IN THE PATIENT AT THE INJECTION SITE. THE CONSUMER VISITED A DOCTOR WHOM ADVISED TO SEEK TREATMENT IN THE ER. AN X-RAY WAS OBTAINED AND THE NEEDLE WAS NOT DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534475 BD NEOFLON¿ IV CANNULA INTRAVASCULAR CATHETER FOZ BECTON DICKINSON AND CO. 7200551 10885403811012

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention