BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE

    MDR report key: 8048174 · Received November 7, 2018

    Report

    Report Number
    1911916-2018-00620
    Event Type
    Malfunction
    Date Received
    November 7, 2018
    Date of Event
    October 18, 2018
    Report Date
    December 6, 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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE PHOTO OF AN UNSHIELDED NEEDLE WAS ATTACHED FOR EVALUATION. A FIBER IS NOTED ON THE NEEDLE. THE DEFECT IS CONFIRMED AS REPORTED. THE FIBER COULD HAVE COME FROM A CLEANING CLOTH, OR THE SURROUNDING ENVIRONMENT. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME AS THE DEFECT RATE IS WITHIN ALLOWED QUALITY LIMITS PER BD¿S SPECIFICATIONS. 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED. TWO ASSEMBLY BATCHES WERE USED IN THE PRODUCTION OF THIS ORDER. ASSEMBLY BATCH 6243597 HAD 171 VISUAL INSPECTIONS PERFORMED ON 8,550 PARTS WITH ZERO DEFECTS NOTED. DAILY CLEANING WAS PERFORMED SIX TIMES DURING THE ASSEMBLY OF THIS BATCH. ASSEMBLY BATCH 6271680 HAD 245 VISUAL INSPECTIONS PERFORMED ON 12,250 PARTS WITH ONE DEFECT RECORDED FOR THE LOW LUBE SOLIDS MENTIONED ABOVE. DAILY CLEANING WAS PERFORMED 30 TIMES DURING THE ASSEMBLY OF THIS BATCH. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCH. THE FIBER COULD HAVE COME FROM A CLEANING CLOTH, OR THE SURROUNDING ENVIRONMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE HAD FOREIGN MATTER ON THE NEEDLE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    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 BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE HAD FOREIGN MATTER ON THE NEEDLE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888361 BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 6270713 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other