BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILLINOIS (TJ) NEEDLE ASPIRATION 15GA

    MDR report key: 8155569 · Received December 12, 2018

    Report

    Report Number
    1625685-2018-00061
    Event Type
    Injury
    Date Received
    December 12, 2018
    Date of Event
    November 20, 2018
    Report Date
    January 21, 2019
    Manufacturer
    CAREFUSION, INC
    Product Code
    LWE
    PMA / PMN Number
    K913306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP EMDR FOR DEVICE EVALUATION: TWO SAMPLES WERE RECEIVED FOR EVALUATION. VISUAL EXAMINATION OF THE PROVIDED SAMPLES CONFIRMED THE REPORTED FAILURE MODE (MISSING PROTECTIVE SLEEVE). A DEVICE HISTORY RECORD REVIEW OF ALL APPLICABLE MANUFACTURING RECORDS FOR LOT 0001200458 DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. THE MOST PROBABLE ROOT CAUSE FOR THE MISSING PROTECTIVE SLEEVE WAS INADVERTENT ERROR BY THE MANUFACTURING ASSOCIATE DURING THE ASSEMBLY PROCESS FOR THE NEEDLE. BASED ON THE IDENTIFIED PROBABLE ROOT CAUSE, ALL APPLICABLE MANUFACTURING AND QUALITY ASSOCIATES WILL RECEIVE AWARENESS TRAINING REGARDING THE PROPER MANUFACTURING PROCESSES FOR THE ASSEMBLY OF THE IDENTIFIED PRODUCT CODE. THIS COMPLAINT WILL BE ENTERED INTO THE COMPLAINT MANAGEMENT SYSTEM AND WILL BE TRACKED AND TRENDED FOR FUTURE OCCURRENCES THROUGH THE QUALITY DATA ANALYSIS PROCESS.

    Description of Event or Problem · 0

    JUST HAD ANOTHER BONE MARROW NEEDLE WITHOUT THE SAFETY COVER ON TODAY, AND UNFORTUNATELY, IT RESULTED IN A NEEDLE STICK TO THE STAFF MEMBER. THIS WAS NOT PART OF A LARGER KIT. IT WAS A SINGLE NEEDLE PACK THAT THE NURSE WAS PULLING OUT OF A STORAGE BIN. IT LOOKS LIKE THE NEEDLE ALSO PUNCTURED THE NEEDLE PACKAGE THAT WAS NEXT TO IT IN THE BIN, SO WE CAN NO LONGER CONSIDER THAT NEEDLE STERILE. (B)(6) 2018 CUSTOMER RESPONSE: IT WAS NOT RECORDED OR SPECIFIED THAT A MEDICAL INTERVENTION TOOK PLACE.

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    JUST HAD ANOTHER BONE MARROW NEEDLE WITHOUT THE SAFETY COVER ON TODAY, AND UNFORTUNATELY, IT RESULTED IN A NEEDLE STICK TO THE STAFF MEMBER. THIS WAS NOT PART OF A LARGER KIT. IT WAS A SINGLE NEEDLE PACK THAT THE NURSE WAS PULLING OUT OF A STORAGE BIN. IT LOOKS LIKE THE NEEDLE ALSO PUNCTURED THE NEEDLE PACKAGE THAT WAS NEXT TO IT IN THE BIN, SO WE CAN NO LONGER CONSIDER THAT NEEDLE STERILE. ON (B)(6) 2018 CUSTOMER RESPONSE: IT WAS NOT RECORDED OR SPECIFIED THAT A MEDICAL INTERVENTION TOOK PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997955 ILLINOIS (TJ) NEEDLE ASPIRATION 15GA BONE MARROW COLLECTION/TRANSFUSION KIT LWE CAREFUSION, INC 1200458

    Patients

    Seq Age Sex Outcome Treatment
    1 Other