BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 8597175 · Received May 9, 2019

    Report

    Report Number
    1024879-2019-00862
    Event Type
    Malfunction
    Date Received
    May 9, 2019
    Date of Event
    April 15, 2019
    Report Date
    May 20, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686075
    PMA / PMN Number
    K982541
    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 SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE INCIDENT LOT 9003943; HOWEVER, THE CUSTOMER PROVIDED SAMPLES FROM LOT 8298865. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR SAFETY SHIELD SEPARATION WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BOTH 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: BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR SAFETY SHIELD SEPARATION WITH THE INCIDENT LOT WAS OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, 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 FAILURE OCCURRED WITH A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MATERIAL NO. 368607, BATCH NO. 9003943. IT WAS REPORTED THAT THE SHIELD FALLS OFF FROM THE VACUTAINER HOLDER LEAVING THE NEEDLE UNCOVERED AND RISKING THE SAFETY OF THE PHLEBOTOMIST. (B)(6) 2019 INCIDENT (1 OF 5). 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. THESE ARE THE LOT NUMBERS THAT WE WERE ABLE TO TRACK TO THOSE NEEDLESS (9038652 & 9003943). ALSO, ONE OF THE PHLEBOTOMIST AT ONE HOSPITAL USED TO WORK IN ANOTHER FACILITY THAT HAS BEEN USING THE BD VACUTAINER/NEEDLE ECLIPSE FOR A WHILE AND SHE 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 THE HOSPITAL CONTINUES 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. PLEASE ADVISE WHAT STEPS WE SHOULD TAKE TO RESOLVE THIS AND TO PREVENT ANY FUTURE INJURIES TO OUR EMPLOYEES."

    Additional Manufacturer Narrative · 1

    THE REPORTED LOT# 9038652 WAS NOT FOUND FOR THE CATALOG NUMBER. 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 SAFETY SHIELD FAILURE OCCURRED WITH A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MATERIAL NO. 368607, BATCH NO. 9003943. IT WAS REPORTED THAT THE SHIELD FALLS OFF FROM THE VACUTAINER HOLDER LEAVING THE NEEDLE UNCOVERED AND RISKING THE SAFETY OF THE PHLEBOTOMIST. (B)(6) 2019 INCIDENT (1 OF 5). 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. THESE ARE THE LOT NUMBERS THAT WE WERE ABLE TO TRACK TO THOSE NEEDLESS (9038652 & 9003943). ALSO, ONE OF THE PHLEBOTOMIST AT ONE HOSPITAL USED TO WORK IN ANOTHER FACILITY THAT HAS BEEN USING THE BD VACUTAINER/NEEDLE ECLIPSE FOR A WHILE AND SHE 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 THE HOSPITAL CONTINUES THE TRANSITION TO THIS PRODUCT WE ARE EXTREMELY WORRIED AND UNSURE HOW OUR LARGES 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. PLEASE ADVISE WHAT STEPS WE SHOULD TAKE TO RESOLVE THIS AND TO PREVENT ANY FUTURE INJURIES TO OUR EMPLOYEES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387521 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 9003943 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 Other