BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 7148744 · Received December 27, 2017

    Report

    Report Number
    1024879-2017-01286
    Event Type
    Injury
    Date Received
    December 27, 2017
    Date of Event
    December 6, 2017
    Report Date
    January 30, 2018
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686082
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON THE INITIAL MDR THE LOT NUMBER WAS INCORRECT. THE CORRECT LOT NUMBER IS 7243791. MEDICAL DEVICE EXPIRATION DATE = 8/31/2022. DEVICE MANUFACTURE DATE = 8/31/2017. INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR SAFETY SHIELD SEPARATION WITH THE INCIDENT LOT WAS NOT OBSERVED. EACH SAMPLE WAS HAND ACTIVATED TO EVALUATE THE FUNCTION OF THE SAFETY SHIELD. THE SAFETY SHIELD WAS ROTATED BACKWARDS WITH EASE WITH NO IV SHIELD LIFT IDENTIFIED. THE SAFETY SHIELD WAS THEN ENGAGED OVER THE IV NEEDLE. THE LOCK-OUT FEATURES ENGAGED APPROPRIATELY AND NO BREAKAGE, FULL OR PARTIAL DISENGAGEMENT OF THE SAFETY SHIELD FROM THE BODY OF THE UNIT WAS IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH A CAPA AND POTENTIAL CAUSES FROM THE MANUFACTURING PROCESS HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED AND ARE IN THE PROCESS OF BEING IMPLEMENTED. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR SAFETY SHIELD SEPARATION WITH THE INCIDENT LOT WAS NOT OBSERVED. HOWEVER, FURTHER INVESTIGATION ACTIVITIES HAVE BEEN CONDUCTED RELATING TO THIS PRODUCT ISSUE AND POSSIBLE ROOT CAUSES FROM THE MANUFACTURING PROCESS HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS AND PROCEDURES ARE BEING IMPLEMENTED TO MITIGATE FURTHER OCCURRENCES. ROOT CAUSE DESCRIPTION: BD HAS INITIATED FURTHER INVESTIGATION THROUGH A CAPA. THE INVESTIGATION HAS IDENTIFIED POSSIBLE ROOT CAUSES FROM THE MANUFACTURING PROCESS AND CORRECTIVE ACTIONS ARE IN THE PROCESS OF BEING IMPLEMENTED. CAPA (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED LOT # DOES NOT EXIST FOR THE REPORTED CAT #. THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER USE OF THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE. ONE OF THE PHLEBOTOMISTS HAD A NEEDLE STICK. SHE ENGAGED THE SAFETY DEVICE ON AN ECLIPSE NEEDLE, IT SLIPPED TO THE SIDE AND CAUSED THE NEEDLE STICK. BLOOD BORNE PATHOGEN EXPOSURE (NSI). EMPLOYEE HEALTH VISIT. EMPLOYEE HEALTH TESTED SOURCE PATIENT AND TESTED CLINICIAN. RESULTS NOT YET AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927127 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE SAFETY ENGINEERED SAMPLE NEEDLE FMI BECTON, DICKINSON & CO., (BD) 7243791 50382903686082

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention