BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 30X1/2 RB

    MDR report key: 10347800 · Received July 30, 2020

    Report

    Report Number
    1911916-2020-00695
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Date of Event
    June 25, 2020
    Report Date
    July 31, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 7/30/2020. H.6. INVESTIGATION: FIFTEEN SAMPLES WERE RECEIVED AND EVALUATED. THE PACKAGING BLISTERS WITH THE TOP WEB MARKED ARE 305106 30X ½¿; HOWEVER, THE NEEDLE ASSEMBLIES INSIDE THE PACKAGING BLISTERS HAVE A 1¿ NEEDLE. ONE PHOTO WAS PROVIDED. THE PHOTO SHOWS FOUR PACKAGING BLISTERS WITH NEEDLE ASSEMBLIES WITH A 1¿ NEEDLE. A POTENTIAL ROOT CAUSE IS ASSOCIATED WITH THE PACKAGING PROCESS, NEEDLES WITH 1¿ LENGTH WERE FED TO THE MACHINE, AND NOT DETECTED DURING THE INSPECTIONS. BASED ON THE INVESTIGATION AND THE ANALYSIS OF THE SAMPLES AND PHOTOS PROVIDED, THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLES IN THE PACKAGE ARE NOT ALL THE CORRECT SIZE. THIS OCCURRED ON 100 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305106 BATCH NO: 9193522 IT WAS REPORTED THAT THE NEEDLES INSIDE THE PACKAGE ARE NOT ALL THE CORRECT SIZE. SOME ARE 1/2" AND SOME ARE 1".

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLES IN THE PACKAGE ARE NOT ALL THE CORRECT SIZE. THIS OCCURRED ON 100 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305106 BATCH NO: 9193522. IT WAS REPORTED THAT THE NEEDLES INSIDE THE PACKAGE ARE NOT ALL THE CORRECT SIZE. SOME ARE 1/2" AND SOME ARE 1".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808480 NEEDLE 30X1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305106 9193522 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other