BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 8061146 · Received November 12, 2018

    Report

    Report Number
    1920898-2018-00880
    Event Type
    Malfunction
    Date Received
    November 12, 2018
    Date of Event
    November 1, 2018
    Report Date
    December 12, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) LOOSE 3/10CC, 6MM SYRINGES. CUSTOMER STATES THAT THERE ARE BLACK SMEARS INSIDE THE SYRINGE. BOTH RETURNED SYRINGES WERE EXAMINED AND BOTH EXHIBITED DARK MATERIAL ON THE SURFACE OF THE BARREL. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY SCALE PRINT INK MIXED WITH SILICONE. CAPA 162566 WAS INITIATED TO ADDRESS SUCH ISSUES AT THIS TIME. SAMPLES WERE FORWARDED TO MANUFACTURING (HOLDREGE) ON 30NOV2018 FOR FURTHER REVIEW. ON 04DEC2018, HOLDREGE RECEIVED TWO (2) LOOSE 0.3ML, 6MM, 31G SYRINGES FROM REPORTED BATCH# 7352721. ALL SAMPLES ARE DECONTAMINATED PER HSTR-17 AND HQA-68 PRIOR TO BEING EVALUATED. UPON EVALUATION BY QE AH, SIMILAR FINDINGS TO THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD FRANKLIN LAKES WERE NOTED. PER FTIR ANALYSIS, THE MATERIAL IS MOST LIKELY SCALE PRINT INK AND SILICONE. THE RETURNED SAMPLES WERE VISUALLY INSPECTED AND NOTED THAT THE DEFECT FOUND WITHIN THESE SAMPLES IS TERMED IN THE MANUFACTURING PLANT AS "SMOKY PRINT". THIS CAN OCCUR WHEN THE EXCESS INK IS NOT SUCCESSFULLY REMOVED FROM THE PAD AND/OR IF THE PAD HAS BECOME SWOLLEN. CURRENTLY, THE HOLDREGE PLANT IS EXPLORING IMPROVEMENT PROJECTS THAT MAY ASSIST IN DRIVING PRINT-RELATED DEFECTS DOWN. NO ADDITIONAL ACTIONS AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7352721. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FIVE (5) NOTIFICATIONS [200736062, 200736216, 200735882, 200735897, 200735784] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 3RD RELATED COMPLAINT FOR FOREIGN MATTER (INSIDE SYRINGE) ON LOT # 7352721. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE CONTAINED FOREIGN MATTER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    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 INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE CONTAINED FOREIGN MATTER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901929 BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE SYRINGE FMF BD MEDICAL - DIABETES CARE 7352721 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other