BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD ECLIPSE

    MDR report key: 8575624 · Received May 2, 2019

    Report

    Report Number
    1024879-2019-00816
    Event Type
    Malfunction
    Date Received
    May 2, 2019
    Date of Event
    April 17, 2019
    Report Date
    May 20, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMF
    UDI-DI
    50382903686075
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. HOWEVER, THE CUSTOMER PROVIDED TWO POTENTIAL LOT NUMBERS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE POTENTIAL INCIDENT LOTS 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. INVESTIGATION CONCLUSION: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. ROOT CAUSE DESCRIPTION: AS THERE WAS NO SAMPLE OR PHOTO AVAILABLE FOR EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SAFETY SHIELD FALLS OFF WITH AN UNSPECIFIED BD ECLIPSE¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE SHIELD FALLS OFF FROM THE VACUTAINER HOLDER LEAVING THE NEEDLE UNCOVERED AND RISKING THE SAFETY OF THE PHLEBOTOMIST. UNKNOWN INCIDENT DATE (4 OF 5) POSSIBLE LOTS 9038652, 9003943. UNFORTUNATELY, IN THE LAST FEW DAYS WE HAVE BEEN MADE AWARE BY THE STAFF OF A CURRENT SAFETY ISSUE THAT HAS BEEN HAPPENING FOR A FEW WEEKS WITH OUR NEW BD VACUTAINER/NEEDLES ECLIPSE. THE ISSUE IS, THAT AT TIMES WHEN THE PHLEBOTOMIST ARE GOING TO CLOSE THE SAFETY SHIELD OF THE NEEDLE AFTER A BLOOD COLLECTION THE SHIELD HAS FALLEN OFF FROM THE VACUTAINER HOLDER LEAVING THE NEEDLE UNCOVERED AND RISKING THE SAFETY OF THE PHLEBOTOMIST. MENTIONED TO HER SUPERVISOR THAT THIS IS NOT A NEW ISSUE FOR THIS PRODUCT. IN ADDITION, ANOTHER CONCERN FROM OUR PHLEBOTOMISTS IS THAT VERY OFTEN AFTER TIGHTENING THE NEEDLES TO THE VACUTAINER HOLDER, THE NEEDLES DO NOT ALIGN PROPERLY WITH THE CENTER OF THE HOLDER MAKING IT HARDER TO HOLD DURING BLOOD COLLECTION. AS WE CONTINUE THE TRANSITION TO THIS PRODUCT WE ARE EXTREMELY WORRIED AND UNSURE HOW OUR LARGEST FACILITY IS GOING TO DEAL WITH THESE ISSUES TAKING INTO CONSIDERATION THAT 99% OF BLOOD COLLECTION AT THIS FACILITY IS PERFORMED BY NON-LAB PERSONNEL. NO PATIENT IDENTIFIERS AVAILABLE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THAT SAFETY SHIELD FALLS OFF WITH AN UNSPECIFIED BD ECLIPSE¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE SHIELD FALLS OFF FROM THE VACUTAINER HOLDER LEAVING THE NEEDLE UNCOVERED AND RISKING THE SAFETY OF THE PHLEBOTOMIST. UNKNOWN INCIDENT DATE (4 OF 5) POSSIBLE LOTS 9038652, 9003943. UNFORTUNATELY, IN THE LAST FEW DAYS WE HAVE BEEN MADE AWARE BY THE STAFF OF A CURRENT SAFETY ISSUE THAT HAS BEEN HAPPENING FOR A FEW WEEKS WITH OUR NEW BD VACUTAINER/NEEDLES ECLIPSE. THE ISSUE IS, THAT AT TIMES WHEN THE PHLEBOTOMIST ARE GOING TO CLOSE THE SAFETY SHIELD OF THE NEEDLE AFTER A BLOOD COLLECTION THE SHIELD HAS FALLEN OFF FROM THE VACUTAINER HOLDER LEAVING THE NEEDLE UNCOVERED AND RISKING THE SAFETY OF THE PHLEBOTOMIST. MENTIONED TO HER SUPERVISOR THAT THIS IS NOT A NEW ISSUE FOR THIS PRODUCT. IN ADDITION, ANOTHER CONCERN FROM OUR PHLEBOTOMISTS IS THAT VERY OFTEN AFTER TIGHTENING THE NEEDLES TO THE VACUTAINER HOLDER, THE NEEDLES DO NOT ALIGN PROPERLY WITH THE CENTER OF THE HOLDER MAKING IT HARDER TO HOLD DURING BLOOD COLLECTION. AS WE CONTINUE THE TRANSITION TO THIS PRODUCT WE ARE EXTREMELY WORRIED AND UNSURE HOW OUR LARGEST FACILITY IS GOING TO DEAL WITH THESE ISSUES TAKING INTO CONSIDERATION THAT 99% OF BLOOD COLLECTION AT THIS FACILITY IS PERFORMED BY NON-LAB PERSONNEL. NO PATIENT IDENTIFIERS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365346 UNSPECIFIED BD ECLIPSE SYRINGE FMF BECTON, DICKINSON & CO., (BD) UNKNOWN 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 Other