BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSULIN PEN NEEDLE 31G X 5MM

    MDR report key: 7200485 · Received January 17, 2018

    Report

    Report Number
    9616656-2017-00190
    Event Type
    Injury
    Date Received
    January 17, 2018
    Date of Event
    December 22, 2017
    Report Date
    February 26, 2018
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K051899
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: 69 SEALED AND INTACT AND ONE OPEN 31G X 5MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 7052715, CAT. NO. 325104. VISUAL EXAMINATION WAS CARRIED OUT ON THE OPENED SAMPLE AND A BROKEN PATIENT END OF NEEDLE WAS OBSERVED. INDENTATION ON THE HUB WAS ALSO OBSERVED. VISUAL EXAMINATION WAS ALSO CARRIED OUT ON 30 OF THE SEALED SAMPLES AND IT WAS OBSERVED THAT ONE SAMPLE HAD A CANNULA THROUGH SHIELD. A CLOG TEST WAS ALSO CARRIED OUT ON 30 SAMPLES AND NO ISSUES WERE OBSERVED. VISUAL EXAMINATION WAS CARRIED OUT ON THE OPENED SAMPLE AND A BROKEN PATIENT END OF NEEDLE WAS OBSERVED. INDENTATION ON THE HUB WAS ALSO OBSERVED. VISUAL EXAMINATION WAS ALSO CARRIED OUT ON 30 OF THE SEALED SAMPLES AND IT WAS OBSERVED THAT ONE SAMPLE HAD A CANNULA THROUGH SHIELD. A CLOG TEST WAS ALSO CARRIED OUT ON 30 SAMPLES AND NO ISSUES WERE 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: ROOT CAUSE OF THIS ISSUE WAS INCORRECT LOADING OF THE SHIELD TO THE HUB AT THE SHIELDING STATION. CAPA 131809 WAS OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INSULIN PEN NEEDLE BROKE OFF IN THE THIGH OF THE PATIENT DURING USE. THE PATIENT WENT TO THE CLINIC (B)(6) 2017 FOR X-RAYS HOWEVER THE IMAGES SHOWED NO NEEDLE. THE PATIENT WENT HOME TO OBSERVE THE SITE FOR NEEDLE REVEAL. ON (B)(6) 2017 AGAIN THE NEEDLE BREAKS OFF, TIP COULD NOT BE FOUND. NO MEDICAL INTERVENTION NOTED ON THIS PARTICULAR DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43159 BD INSULIN PEN NEEDLE 31G X 5MM INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 7052715

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention