BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEN NEEDLE¿ ULTRA-FINE III

    MDR report key: 7443330 · Received April 19, 2018

    Report

    Report Number
    9616656-2018-00089
    Event Type
    Malfunction
    Date Received
    April 19, 2018
    Date of Event
    April 2, 2018
    Report Date
    August 23, 2018
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SAMPLES WERE RECEIVED FOR EVALUATION. INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) OPEN 8MM, 31G PEN NEEDLES FROM LOT # 7130915. CUSTOMER STATES THAT THE NEEDLE WAS JAMMED THROUGH THE BLUE PLASTIC PROTECTIVE COVER, MAKING THE NEEDLE UNUSABLE. THE RETURNED PEN NEEDLE WAS EXAMINED AND EXHIBITED THE PATIENT END OF THE CANNULA THROUGH THE INNER SHIELD. CAPA (B)(4) RAISED FOR NEEDLE THROUGH SHIELD ISSUE. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR CANNULA THROUGH SHIELD ON LOT # 7130915. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION IS REQUIRED AT THIS TIME.

    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: DEVICE RETURNED TO MANUFACTURE: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD PEN NEEDLE¿ ULTRA-FINE III THERE WAS AN ISSUE WITH STERILITY. IT WAS STATED BY THE CONSUMER ¿RECENTLY OPENED A NEEDLE TIP ONLY TO DISCOVER THAT THE NEEDLE WAS JAMMED THROUGH THE BLUE PLASTIC PROTECTIVE COVER, MAKING THE NEEDLE UNUSABLE. LUCKILY I DID NOT CUT MY FINGERS ON THE EXPOSED NEEDLE.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD PEN NEEDLE¿ ULTRA-FINE III THERE WAS AN ISSUE WITH STERILITY. IT WAS STATED BY THE CONSUMER ¿RECENTLY OPENED A NEEDLE TIP ONLY TO DISCOVER THAT THE NEEDLE WAS JAMMED THROUGH THE BLUE PLASTIC PROTECTIVE COVER, MAKING THE NEEDLE UNUSABLE. LUCKILY I DID NOT CUT MY FINGERS ON THE EXPOSED NEEDLE.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 WITH THE USE OF THE BD PEN NEEDLE¿ ULTRA-FINE III THERE WAS AN ISSUE WITH STERILITY. IT WAS STATED BY THE CONSUMER ¿RECENTLY OPENED A NEEDLE TIP ONLY TO DISCOVER THAT THE NEEDLE WAS JAMMED THROUGH THE BLUE PLASTIC PROTECTIVE COVER, MAKING THE NEEDLE UNUSABLE. LUCKILY I DID NOT CUT MY FINGERS ON THE EXPOSED NEEDLE.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286193 BD PEN NEEDLE¿ ULTRA-FINE III INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 7130915

    Patients

    Seq Age Sex Outcome Treatment
    1 Other