BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ GENERAL USE STERILE HYPODERMIC NEEDLE

    MDR report key: 7544876 · Received May 25, 2018

    Report

    Report Number
    1911916-2018-00247
    Event Type
    Malfunction
    Date Received
    May 25, 2018
    Date of Event
    May 9, 2018
    Report Date
    June 21, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051275
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLE AVAILABLE FOR EVALUATION. QN REVIEW: NO NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCH. DHR REVIEW: ASSEMBLY BATCH 7201645 HAD 67 VISUAL INSPECTIONS PERFORMED ON (B)(4) PARTS WITH ZERO DEFECTS NOTED. THE ID INSPECTION SYSTEM WAS CHALLENGED 36 TIMES USING (B)(4) PARTS WITH ZERO FAILURES RECORDED. INVESTIGATION CONCLUSION: SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE OR IDENTIFY ANY CORRECTIVE ACTIONS NEEDED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 DURING USE A BD¿ GENERAL USE STERILE HYPODERMIC NEEDLE WAS HAVING FLOW ISSUES GIVING RESISTANCE DURING USE. NO HARM CAUSED, BUT THERE WAS ABOUT A 5 MINUTE DELAY IN PROCEDURE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389106 BD¿ GENERAL USE STERILE HYPODERMIC NEEDLE HYPODERMIC NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 7200552 30382903051275

    Patients

    Seq Age Sex Outcome Treatment
    1 Other