BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE

    MDR report key: 7332260 · Received March 12, 2018

    Report

    Report Number
    1911916-2018-00072
    Event Type
    Malfunction
    Date Received
    March 12, 2018
    Date of Event
    February 16, 2018
    Report Date
    April 11, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A SAMPLE WAS RETURNED FOR EVALUATION. THE RETURNED SAMPLE HAS EPOXY CURED ON THE CANNULA SHAFT THEREFORE FAILURE MODE IS VERIFIED. THIS WOULD HAVE OCCURRED DURING THE MANUFACTURING PROCESS. PROBABLE CAUSES: THE RACK OF NEEDLES FELL AGAINST ANOTHER RACK COMING IN CONTACT WITH UNCURED EPOXY. A MISASSEMBLED NEEDLE WITH UNCURED EPOXY CAME INTO CONTACT WITH THE NEEDLE IN QUESTION DURING ASSEMBLY. EPOXY CONTAMINATED THE CATERPILLAR BELTS ON THE ASSEMBLY LINE AND TRANSFERRED TO THE CANNULA. (THIS IS UNLIKELY IN THIS INSTANCE. THE LOCATION OF THE EPOXY DOES NOT COINCIDE WITH THE CONTACT POINTS OF THE CATERPILLAR BELTS TO THE CANNULA.) A DEVICE HISTORY REVIEW WAS PERFORMED WITH THE FOLLOWING RESULTS: TWENTY-EIGHT VISUAL INSPECTIONS WERE PERFORMED ON 1,680 PARTS WITH ZERO DEFECTS NOTED. CLEANING WAS PERFORMED FOUR TIMES DURING THE PRODUCTION OF THIS BATCH. ASSEMBLY BATCH 4123525 HAD 195 VISUAL INSPECTIONS PERFORMED ON 9,900 PARTS WITH ONE DEFECT NOTED FOR MIXED HUBS. CLEANING WAS PERFORMED 21 TIMES DURING THE PRODUCTION OF THIS BATCH. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCH. HERE ARE THE THINGS WE'VE DONE TO IMPROVE EPOXY SPLATTERS AND DRIPOVERS: RE-TRAINED OPERATORS IN REGARDS TO INSPECTING FOR EPOXY DRIPOVERS AND IDENTIFY EPOXY ISSUES MODIFIED THE LINE TO PREVENT MIS-ASSEMBLED CANNULA FROM ACCUMULATING AND CAUSING EPOXY ON THE CATERPILLAR BELTS AND OTHER NEEDLES REVISED THE VISUAL INSTRUCTION FOR EPOXY APPLICATION TO ASSIST THE OPERATORS IN ADJUSTING THE ADHESIVE CAMERA. THE ADHESIVE CAMERA IS USED TO ASSIST THE ASSEMBLY ASSOCIATE WITH EPOXY ADJUSTMENTS IN REGARDS TO EPOXY LOCATION. IT IS NOT USED TO DISPOSITION PRODUCT. WHILE THESE ACTIONS REDUCE THE INTERACTION REQUIRED FOR THE OPERATOR IN REGARDS TO EPOXY APPLICATION, IT IS STILL DEPENDENT ON THE OPERATOR TO CONTINUOUSLY MONITOR THE ASSEMBLY PROCESS FOR EPOXY ISSUES. WE WILL CONTINUE TO PROVIDE COACHING AND FEEDBACK TO THEM AS WE BECOME AWARE OF ISSUES.

    Additional Manufacturer Narrative · 1

    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 A PHYSICIAN NOTICED A ¿WHITE SUBSTANCE¿ ON THE TIP OF A NEEDLE FROM A BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE PRIOR TO USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176108 BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE HYPODERMIC NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 3218218 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other