BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE 1ML 31GX5/16"

    MDR report key: 6835226 · Received August 31, 2017

    Report

    Report Number
    1920898-2017-00148
    Event Type
    Malfunction
    Date Received
    August 31, 2017
    Date of Event
    August 10, 2017
    Report Date
    October 11, 2017
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (7) LOOSE 1CC, 8MM SYRINGES. CUSTOMER STATES THAT THERE IS EXCESSIVE LUBRICANT INSIDE OF HER SYRINGES. ALL RETURNED SYRINGES WERE EXAMINED AND NO LIQUID WAS OBSERVED IN ANY OF THE SAMPLES. ALL SAMPLES WERE ALSO TESTED AND ONE SAMPLE EXHIBITED A CLEAR DROPLET OF MATERIAL COMING OUT OF THE CANNULA WHEN FULLY DEPRESSING THE PLUNGER ROD. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SUGGESTS THAT THIS MATERIAL HAS COMPONENTS SIMILAR TO THOSE OF SILICONE. DEVICE HISTORY RECORD REVIEW ¿ A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 6116686. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [(B)(4)] WERE INITIATED FOR UNRELATED INCIDENTS AS COMPARED TO THIS COMPLAINT CAUSE. INVESTIGATION CONCLUSION: 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. ROOT CAUSE DESCRIPTION: POSSIBLE ROOT CAUSES FOR EXCESS SILICONE INCLUDE: THE FIRST IS THAT SOME ASSOCIATES DO NOT DEGAS THE SILICONE AFTER REFILLING THE TANKS. SECOND, THE SILICONE VOLUME ON THE PUMP IS A PARAMETER THAT IS BEING ADJUSTED, BUT IS NOT UNDERSTOOD AND COULD BE A POTENTIAL KPIV. CAPA # (B)(4) AND SITUATION ANALYSIS # (B)(4) HAVE BEEN OPENED TO ADDRESS THIS ISSUE. ON 26SEP2017, (B)(4) RECEIVED SEVEN (7) LOOSE 1ML, 8MM, 31GA SYRINGES FROM REPORTED BATCH# 6116686. ALL SAMPLES WERE DECONTAMINATED (B)(4) PRIOR TO EVALUATION. UPON EVALUATION BY QE AH, NO ADDITIONAL REMARKABLE FINDINGS WERE NOTED FROM THOSE DOCUMENTED DURING INITIAL INVESTIGATION IN FRANKLIN LAKES. AS THERE IS NOT A TEST METHOD FOR DETERMINING EXCESS SILICONE, THE MANUFACTURING PLANT IS UNABLE TO CONFIRM THIS COMPLAINT CAUSE. ANALYSIS IN (B)(4) SUPPORTS THE PROBABLE ROOT CAUSE OF SILICONE BEING THE MATERIAL REPORTED BY THE CUSTOMER. THE SILICONE UTILIZED IN THE PRODUCTION OF THE INSULIN SYRINGES IS MEDICAL GRADE SILICONE, IS NON-TOXIC AND SAFE FOR SUBCUTANEOUS INJECTION WITH NO NOTABLE RISK TO THE RECIPIENT. NO ADDITIONAL ACTIONS DEEMED APPROPRIATE BY THE (B)(4) MANUFACTURING PLANT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: N/A. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EXCESSIVE LUBRICANT WAS FOUND IN A BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE 1ML 31GX5/16" BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616439 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE 1ML 31GX5/16" INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 6116686

    Patients

    Seq Age Sex Outcome Treatment
    1 Other