BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 30X1/2 RB

    MDR report key: 11206428 · Received January 21, 2021

    Report

    Report Number
    1911916-2021-00046
    Event Type
    Malfunction
    Date Received
    January 21, 2021
    Date of Event
    December 30, 2020
    Report Date
    January 25, 2021
    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
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305106 AND LOT NUMBER 9193522. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE 30X1/2 RB HAD A MIX OF PRODUCT TYPES IN A PACK BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLES ARE LABLED APPROPRIATELY AS 1/2" BUT THE NEEDLES INSIDE ARE 1." EVENT DESCRIPTION PER ATTACHED EMAIL STATES:REPORTED ISSUE: CUSTOMER RECENT ORDER OF 30G 1/2" NEEDLES ARE LABELED AS 30G 1/2" ON THE BOX AND ON EACH INDIVIDUAL NEEDLE, BUT THEY ARE ACTUALLY 1" NEEDLES. WE KEPT ENCOUNTERING THIS AND THOUGHT WE WERE NUTS, BUT IT KEEPS HAPPENING. WE HAVE TO WASTE THIS NEEDLE EVERY TIME THIS HAPPENS BECAUSE WE ASSUME IT IS A 1/2" NEEDLE UNTIL WE GO TO USE IT AND IT IS 1."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 AN UNSPECIFIED NUMBER OF NEEDLE 30X1/2 RB HAD A MIX OF PRODUCT TYPES IN A PACK BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLES ARE LABELED APPROPRIATELY AS 1/2" BUT THE NEEDLES INSIDE ARE 1". EVENT DESCRIPTION PER ATTACHED EMAIL STATES:REPORTED ISSUE: CUSTOMER RECENT ORDER OF 30G 1/2" NEEDLES ARE LABELED AS 30G 1/2" ON THE BOX AND ON EACH INDIVIDUAL NEEDLE, BUT THEY ARE ACTUALLY 1" NEEDLES. WE KEPT ENCOUNTERING THIS AND THOUGHT WE WERE NUTS, BUT IT KEEPS HAPPENING. WE HAVE TO WASTE THIS NEEDLE EVERY TIME THIS HAPPENS BECAUSE WE ASSUME IT IS A 1/2" NEEDLE UNTIL WE GO TO USE IT AND IT IS 1"."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107820 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