BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 7954200 · Received October 10, 2018

    Report

    Report Number
    1920898-2018-00769
    Event Type
    Malfunction
    Date Received
    October 10, 2018
    Date of Event
    September 17, 2018
    Report Date
    October 18, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249121
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) LOOSE 1CC 6MM SYRINGE. CUSTOMER STATES THAT THE SHIELD WAS MISSING, THE NEEDLE WAS BENT AND NEEDLE WAS STICKING THROUGH THE BAG WHICH CAUSED HIM TO STICK HIS FINGER WHICH BLED A LITTLE AND LEFT A SMALL RED BRUISE. THE SYRINGE WAS RETURNED WITHOUT THE SHIELD AND A BENT CANNULA, WITH THE CANNULA EXPOSED. SINCE THE CANNULA WAS EXPOSED A NEEDLE STICK COULD HAVE OCCURRED WHICH COULD LEAD TO HARM TO THE INDIVIDUAL. SAMPLE WAS FORWARDED TO MANUFACTURING (HOLDREGE) ON 05OCT2018 FOR FURTHER REVIEW. ON 09OCT2018, HOLDREGE RECEIVED ONE (1) LOOSE 1ML, 8MM SYRINGE FROM REPORTED BATCH # 7241585. ALL SAMPLES ARE DECONTAMINATED PER HSTR-17 PRIOR TO BEING EVALUATED. UPON EVALUATION BY QE AH, SIMILAR FINDINGS TO THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD FRANKLIN LAKES WERE NOTED. THE SAMPLE WAS VISUALLY INSPECTED AND THE BARREL TIP WAS NOTED TO BE BROKEN, IN ADDITION TO THE OTHER ISSUES NOTED. ADDITIONALLY, THE BARREL WAS NOTED TO BE BOWED BETWEEN THE 20-40U (20 TO 40 UNITS) SCALE MARKINGS. AS THE SAMPLE WAS RECEIVED WITHOUT THE SHIELD OR PACKAGING, ADDITIONAL CHARACTERISTICS WHICH MAY ASSIST IN DETERMINING ROOT CAUSE ARE NOT AVAILABLE AT THIS TIME. POSSIBLE ROOT CAUSE COULD BE A JAM ON THE FFS (FORM FILL & SEAL) EQUIPMENT DURING FORMING OF THE POLYBAG. WHEN THIS TYPE OF EVENT OCCURS, ANY PORTION OF THE DEVICE MAY BE INVOLVED IN THE JAM AND EXHIBIT VARYING DEGREES OF DAMAGE TO THE INVOLVED PORTION OF THE DEVICE. AS THE RETURNED SAMPLE WAS NOT RECEIVED WITH THE CANNULA SHIELD OR POLYBAG, LIMITED DATA IS AVAILABLE FOR ASSESSMENT INTO THE CAUSE OF THIS DEFECT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7241585. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200713991, 200713211] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. SEVERITY: S_2__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE BENT, NEEDLE STICK BEFORE USE, CANNULA SHIELD MISSING AND BRUISING/BLEEDING ON LOT # 7241585. 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. BASED ON THE ABOVE, NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SHIELD WAS MISSING ON THE BD¿ INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE, AND THE NEEDLE WAS STICKING THROUGH THE BAG, CAUSING A CLEAN NEEDLE STICK. THERE WAS NO REPORT OF EXPOSURE OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THAT THE SHIELD WAS MISSING ON THE BD¿ INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE, AND THE NEEDLE WAS STICKING THROUGH THE BAG, CAUSING A CLEAN NEEDLE STICK. THERE WAS NO REPORT OF EXPOSURE OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793245 BD¿ INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 7241585 00382903249121

    Patients

    Seq Age Sex Outcome Treatment
    1 Other