BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ PEN NEEDLE

    MDR report key: 7889099 · Received September 19, 2018

    Report

    Report Number
    9616656-2018-00193
    Event Type
    Malfunction
    Date Received
    September 19, 2018
    Date of Event
    August 28, 2018
    Report Date
    November 28, 2018
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K100005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: FOUR PHOTOS OF A 32G X 4MM PEN NEEDLE CARTON CONTAINING PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 7101678, CAT. NO. 320477. VISUAL EXAMINATION OF THE RETURNED PHOTOS WAS CARRIED OUT AND IT WAS OBSERVED THAT SOME SAMPLES WERE MISSING THE TEARDROP LABEL. EVIDENCE OF A TEARDROP LABEL BEING APPLIED WAS OBSERVED. 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. INVESTIGATION CONCLUSION: THIS ISSUE OCCURRED DUE TO A MECHANICAL SET UP OF THE TOP SEAL STATION. CAPA (B)(4) WAS RAISED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA-FINE¿ PEN NEEDLE WAS MISSING THE STERILE SEAL WHICH CAUSED A STERILITY BREACH. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER ADDRESS: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRA-FINE¿ PEN NEEDLE WAS MISSING THE STERILE SEAL WHICH CAUSED A STERILITY BREACH. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729196 BD ULTRA-FINE¿ PEN NEEDLE INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 7101678

    Patients

    Seq Age Sex Outcome Treatment
    1 Other