BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ INSULIN PEN NEEDLE

    MDR report key: 7383169 · Received March 29, 2018

    Report

    Report Number
    9616656-2018-00077
    Event Type
    Malfunction
    Date Received
    March 29, 2018
    Date of Event
    September 27, 2017
    Report Date
    April 13, 2018
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403811012
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE OPEN 31G X 5MM PEN NEEDLE SAMPLE AND FOUR PHOTOS WERE RETURNED FROM LOT. NO. 4122221, CAT. NO. 320119. CUSTOMER RETURNED ONE OPEN PEN NEEDLE WITHOUT THE INNER SHIELD, TEAR DROP LABEL, OR OUTER COVER. CUSTOMER STATES THAT THE PEN NEEDLE BROKE OFF INSIDE THE STOMACH. THE RETURNED PEN NEEDLE WAS EXAMINED AND EXHIBITED A BROKEN PATIENT END OF THE CANNULA. MICROSCOPIC EXAMINATION OF THE RETURNED SAMPLE REVEALED CHARACTERISTICS SUCH AS RESIDUAL BENDS ON THE BROKEN HUB END, CRACKED ADHESIVE AND TUBING OVALITY (DEFORMATION FROM THE NORMALLY CIRCULAR CROSS SECTION). WHEN VIEWED TOGETHER, THESE ARE ALL INDICATORS OF BENDING/RE-STRAIGHTENING MODE OF FAILURE. REMOVAL OF SOME OF THE ADHESIVE MADE THIS OBSERVATION MORE APPARENT. FURTHERMORE, THE PRESENCE OF THE DEEP INDENTATION DISPLAYED IN THE ADHESIVE AND PLASTIC HUB AREA, CREATED BY THE CANNULA SHAFT FURTHER ATTESTS TO THE SEVERE BENDING THAT POSSIBLY OCCURRED DURING MANUFACTURING PROCESS. AS PER MANUFACTURING, 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: BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE ROOT CAUSE OF THIS ISSUE WAS INCORRECT LOADING OF THE SHIELD TO THE HUB AT THE SHIELDING STATION. CAPA (B)(4) WAS OPENED TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    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 DURING USE OF THE BD VIVA¿ PEN NEEDLE THE NEEDLE BROKE OFF DURING USE. THE CONSUMER STATED THAT ¿THE NEEDLE BROKE OFF INTO HER STOMACH TWO DAYS IN A ROW (TODAY AND ALSO YESTERDAY) DURING HER INJECTION. STATED THAT SHE DOES NOT RE-USE THE NEEDLES, DOES NOT PRIME. SHE DOES ROTATE THE INJECTION SITE.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223949 BD ULTRA FINE¿ INSULIN PEN NEEDLE INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 4122221 10885403811012

    Patients

    Seq Age Sex Outcome Treatment
    1 Other