BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 12832438 · Received November 17, 2021

    Report

    Report Number
    1911916-2021-01167
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    October 20, 2021
    Report Date
    November 19, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903059059
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 11/15/2021. H.6. INVESTIGATION: IT WAS REPORTED THE RUBBER STOPPER IS SKEWED. TO AID IN THE INVESTIGATION, TWO SAMPLES IN OPENED PACKAGING BLISTERS AND TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. EACH OF THE SAMPLES HAS RESIDUES OF A BROWN DRUG ADHERED TO THE RUBBER STOPPER. THE RUBBER STOPPERS ARE PROPERLY ASSEMBLED TO THE PLUNGER ROD. THE CUSTOMER HAS OBSERVED AN ACCEPTABLE IMPERFECTION. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. IN THE TWO PHOTOS PROVIDED, ONE PHOTO SHOWS A SYRINGE AND THE OTHER PHOTO SHOWS TWO PACKAGING BLISTERS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305905, LOT NUMBER 1081066. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. MONITORING OF THE SYRINGE STOPPER WILL BE DONE DURING INSPECTIONS TO VERIFY IF AN UNACCEPTABLE PRODUCT HAS BEEN ASSEMBLED OR PACKAGED. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED WHEN USING THE BD SAFETYGLIDE¿ NEEDLE THE STOPPER WAS DEFECTIVE/DEFORMED/MISALIGNED. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE NEEDLE CORE RUBBER STOPPER IS SKEWED."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD SAFETYGLIDE¿ NEEDLE THE STOPPER WAS DEFECTIVE/DEFORMED/MISALIGNED. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE NEEDLE CORE RUBBER STOPPER IS SKEWED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1727222 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305905 1081066 30382903059059

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown