BEUDAMED
    FDA Adverse Event Injury Summary report: N

    31 G X 5 MM BD ULTRA FINE¿ INSULIN PEN NEEDLE

    MDR report key: 5405393 · Received February 2, 2016

    Report

    Report Number
    9616656-2016-00007
    Event Type
    Injury
    Date Received
    February 2, 2016
    Date of Event
    January 8, 2016
    Report Date
    February 22, 2016
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SECTION H, DEVICE EVALUATION: RESULT - THE CUSTOMER RETURNED (2) 5MM, 31G PEN NEEDLES (1 OPEN, 1 SEALED) WITH THE SHELF CARTON FROM LOT # 5092482 AND (1) LEVEMIR FLEXTOUCH PEN. THE CUSTOMER STATES THAT THE NEEDLE BROKE OFF IN THE SITE. BOTH RETURNED PEN NEEDLES WERE EXAMINED AND THE OPEN SAMPLE EXHIBITED A BROKEN IV 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 EPOXY 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. THE INNER SHIELD WAS ALSO EXAMINED AND EXHIBITED A HOLE THROUGH THE INNER SHIELD WHICH SUGGESTS THAT THE IV END OF THE CANNULA WAS THROUGH THE INNER SHIELD. THE RETURNED SAMPLES AND PHOTOS FROM THE INITIAL INVESTIGATION WERE FORWARDED TO THE MANUFACTURING SITE FOR FURTHER INVESTIGATION. A 10X VISUAL EXAMINATION FOUND ONE PEN NEEDLE WITH BROEN CANNULA IV END. INDENTATION ON THE HUB POST AND HOLE IN THE SHIELD WERE OBSERVED. THE SECOND SAMPLE WAS FOUND TO BE GOOD. AN NOE WAS RAISED DURING MANUFACTURING FOR THIS LOT FOR NEEDLE THROUGH THE SHIELD. NO QUALITY NOTIFICATIONS WERE RAISED. A REVIEW OF THE DEVICE HISTORY RECORD WAS CARRIED OUT. IN-PROCESS INSPECTIONS WERE REVIEWED AND THERE WAS AN ISSUE OBSERVED DURING START OF SHIFT CHECKS ON THE SWANSON UNIT NEEDLE THROUGH SHIELD STATION. THE UNIT WAS NOT DETECTING NEEDLE THROUGH SHIELD. AQ IN PROCESS INSPECTIONS WERE REVIEWED AND NO ISSUES WERE OBSERVED. FINAL INSPECTIONS WERE REVIEWED AND NO ISSUES WERE FOUND. A REVIEW OF CORRECTIVE MAINTENANCE RECORDS FOR THIS LOT WAS CARRIED OUT. MWR-20641-DL WAS RAISED ON STATION 21 LINE 12. THIS CORRECTIVE MAINTENANCE RECORD WAS RAISED TO FIX A DETECTION ISSUE RAISED DURING THE START OF SHIFT MACHINE CHALLENGES. CONCLUSION - BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE. THE DAMAGE OBSERVED TO THE SHIELD WHERE THE NEEDLE HAS PENETRATED INDICATED DURING EVALUATION WOULD SUGGEST THAT THIS IS A NEEDLE THROUGH SHIELD FAILURE MODE. THE POTENTIAL CAUSE OF THIS ISSUE LIES AT THE SHIELDING STATION IN BD ASSEMBLY PROCESS. IF THE NEEDLE IS PRESENTED TO THE SHIELDER OBLIQUELY, THE DOWNWARD MOVEMENT OF THE EMPTY SHIELD RESULTS IN THE NEEDLE PENETRATING THE SHIELD. CAPA (B)(4) WAS RAISED FOR THE NEEDLE THROUGH SHIELD ISSUE. THIS CAPA IS CURRENTLY AT IMPLEMENTATION STAGE, AND THE ASSOCIATED CORRECTIVE ACTIONS ARE DUE FOR COMPLETION JULY 1, 2016. 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.[(B)(6)] .

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: THIS DEVICE DOES NOT HAVE AN EXPIRATION DATE. DEVICE EVALUATION: A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN SHE WAS GIVING HERSELF AN INJECTION WITH THE SUSPECT DEVICE, SHE FELT THE MEDICATION RUNNING FROM THE SITE. THE CUSTOMER FELT LIKE THE NEEDLE HAD BROKEN OFF IN THE INJECTION SITE. SHE USED A DIFFERENT NEEDLE TO INJECT A NEW DOSE IN A DIFFERENT AREA. THE CUSTOMER WHEN TO HER PRIMARY CARE DOCTOR ON (B)(6) 2016 AND THE DOCTOR REPORTED THE NEEDLE WAS STILL IN THE SITE. THE CUSTOMER WENT TO A SPECIALIST WHO SENT HER FOR AN ULTRASOUND. SHE WAS TOLD BY THE ULTRASOUND TECH THAT SHE NEEDS TO GET A CT SCAN, BUT ONE HAD NOT BEEN SCHEDULED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63034 31 G X 5 MM BD ULTRA FINE¿ INSULIN PEN NEEDLE INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 5092482

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention