BEUDAMED
    FDA Adverse Event Injury Summary report: N

    27 G X 3 1/2 IN. BD¿ WHITACRE HIGH FLOW, PENCIL POINT NEEDLE

    MDR report key: 5826894 · Received July 27, 2016

    Report

    Report Number
    2618282-2016-00004
    Event Type
    Injury
    Date Received
    July 27, 2016
    Date of Event
    June 15, 2016
    Report Date
    September 9, 2016
    Manufacturer
    BD CARIBE LTD.
    Product Code
    BSP
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: RESULT - BD RECEIVED FOR INVESTIGATION FOUR BD 27GA 3 ½¿ WHITACRE SPINAL NEEDLES (CAT # 405079, POSSIBLE LOTS # 5062666, 4162967, 5114909), TWO WITH OPEN BLISTERPACK AND TWO WITH NO PACKAGING. THE RETURNED SAMPLES WERE VISUALLY EXAMINED FOR CUSTOMER¿S REPORTED ISSUE. IT WAS INDICATED THAT ONE NEEDLE WAS RETURNED BROKEN. A REVIEW OF THE DEVICE RECORDS REVEALED NO ABNORMALITIES DURING THE MANUFACTURER OF THE REPORTED POTENTIAL LOT NUMBERS. ALL INSPECTIONS WERE PERFORMED ACCORDINGLY AND MET QC SPECIFICATIONS AND NO NCMR'S WERE GENERATED THAT COULD BE RELATED TO THE REPORTED EVENT. A MANUFACTURING REVIEW WAS PERFORMED AND NO ABNORMALITIES WERE REPORTED. CONCLUSION - BD WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE. THE REPORTED CONDITION OF BROKEN NEEDLE BASED ON THE INVESTIGATION RESULTS IS NOT RELATED TO MANUFACTURING. THE FAILURE MODE COULD BE ASSOCIATED TO THE INSERTION TECHNIQUE USED BY THE PHYSICIAN. AS THE ACTUAL LOT NUMBER INVOLVED IN THIS INCIDENT WAS NOT PROVIDED, AN ABSOLUTE ROOT CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #; MEDICAL DEVICE EXPIRATION DATE; SECTION H, DEVICE MANUFACTURE DATE. THE EXACT LOT NUMBER INVOLVED IN THIS INCIDENT IS UNKNOWN. THE CUSTOMER PROVIDED THE FOLLOWING POTENTIAL LOT NUMBERS: 4162967 - MEDICAL DEVICE EXPIRATION DATE 06/30/2019, DEVICE MANUFACTURE DATE 06/11/2014. 5062666 - MEDICAL DEVICE EXPIRATION DATE 03/31/2020, DEVICE MANUFACTURE DATE 03/03/2015. 5114909 - MEDICAL DEVICE EXPIRATION DATE 05/31/2020, DEVICE MANUFACTURE DATE 04/24/2015. DEVICE EVALUATION: IT IS UNKNOWN IF A SAMPLE WILL BE RETURNED FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUSPECT DEVICE BROKE OFF WHILE IT WAS INSERTED IN A PATIENT. THE PATIENT HAD SURGICAL REMOVAL OF THE BROKEN PIECE OF NEEDLE. THE NEEDLE WAS SUCCESSFULLY RETRIEVED AND THE PATIENT DIDN'T REQUIRE FURTHER INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479510 27 G X 3 1/2 IN. BD¿ WHITACRE HIGH FLOW, PENCIL POINT NEEDLE ANESTHESIA SPINAL NEEDLE BSP BD CARIBE LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention