BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE

    MDR report key: 11215974 · Received January 22, 2021

    Report

    Report Number
    1024879-2021-00041
    Event Type
    Injury
    Date Received
    January 22, 2021
    Date of Event
    December 28, 2020
    Report Date
    February 10, 2021
    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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED FIFTEEN (15) SAMPLES AND TWO (2) PHOTOS FROM THE CUSTOMER FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR DEFECTIVE LOCKING MECHANISM WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, ALL CUSTOMER SAMPLES WERE EVALUATED BY FUNCTIONAL TESTING AND THE INDICATED FAILURE MODE FOR DEFECTIVE LOCKING MECHANISM WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HAD A SAFETY SHIELD FAILURE THAT RESULTED IN A NEEDLE STICK INJURY AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO. 368607, BATCH NO. 0248412. IT WAS REPORTED THAT ON 12/28/2020, A PHLEBOTOMIST POKED HERSELF DUE TO A FAULTY SAFETY. WE HAVE HAD TWO INCIDENTS OF NEEDLE STICKS DUE TO FAULTY SAFETY¿S ON THE BD 21G NEEDLES. I HAVE INVESTIGATED AND BELIEVE IT IS ONLY LOT # 0248412, ATTACHED ARE PICTURES. THE FIRST INCIDENT HAPPENED ON 12/26/20, THE PHLEBOTOMIST ACTIVATED THE SAFETY AND PLACED THE NEEDLE ON THE BED. WHEN SHE PICKED IT UP TO DISPOSE THE SAFETY HAD FALLEN AND SHE POKED HERSELF, MIDAS # 20-3862848. THE SECOND INCIDENT HAPPENED ON 12/28/20, A DIFFERENT PHLEBOTOMIST ACTIVATED THE SAFETY AND THEN PLACED THE NEEDLE DOWN. WHEN SHE PICKED IT UP TO DISPOSE SHE POKED HERSELF AND NOTICED THE NEEDLE WAS TO SIDE OF THE SAFETY DEVICE, MIDAS # 20-3890634. I HAVE ASKED OTHER PHLEBOTOMISTS AND THEY HAVE STATED ISSUES WITH THE SAFETY FALLING OFF FOR A COUPLE WEEKS NOW BUT THEY HAVE NOT POKED THEMSELVES. SOME ALSO MENTIONED THE OTHER END OF THE NEEDLE DOES NOT SCREW ONTO THE HUB CORRECTLY. THEY HAVE EITHER HAD TO DISPOSE OF THE NEEDLE OR THEY REALIZED THE HUB WAS LOOSE IN THE MIDDLE OF THE VENIPUNCTURE. I ONLY HAVE 15 BOXES OF LOT 0248412, SO THEY MAY HAVE BEEN USING THEM FOR A WHILE. THEY HAVE BEEN REMOVED FROM USE. THE NEWER LOTS I CURRENTLY HAVE ARE 0260549 AND 0135002.".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HAD A SAFETY SHIELD FAILURE THAT RESULTED IN A NEEDLE STICK INJURY AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO. (B)(4) BATCH NO. 0248412. IT WAS REPORTED THAT ON (B)(6) 2020, A PHLEBOTOMIST POKED HERSELF DUE TO A FAULTY SAFETY. WE HAVE HAD TWO INCIDENTS OF NEEDLE STICKS DUE TO FAULTY SAFETY¿S ON THE BD 21G NEEDLES. I HAVE INVESTIGATED AND BELIEVE IT IS ONLY LOT # 0248412, ATTACHED ARE PICTURES. THE FIRST INCIDENT HAPPENED ON (B)(6) 2020, THE PHLEBOTOMIST ACTIVATED THE SAFETY AND PLACED THE NEEDLE ON THE BED. WHEN SHE PICKED IT UP TO DISPOSE THE SAFETY HAD FALLEN AND SHE POKED HERSELF, MIDAS # 20-3862848. THE SECOND INCIDENT HAPPENED ON (B)(6) 2020, A DIFFERENT PHLEBOTOMIST ACTIVATED THE SAFETY AND THEN PLACED THE NEEDLE DOWN. WHEN SHE PICKED IT UP TO DISPOSE SHE POKED HERSELF AND NOTICED THE NEEDLE WAS TO SIDE OF THE SAFETY DEVICE, MIDAS # 20-3890634. I HAVE ASKED OTHER PHLEBOTOMISTS AND THEY HAVE STATED ISSUES WITH THE SAFETY FALLING OFF FOR A COUPLE WEEKS NOW BUT THEY HAVE NOT POKED THEMSELVES. SOME ALSO MENTIONED THE OTHER END OF THE NEEDLE DOES NOT SCREW ONTO THE HUB CORRECTLY. THEY HAVE EITHER HAD TO DISPOSE OF THE NEEDLE OR THEY REALIZED THE HUB WAS LOOSE IN THE MIDDLE OF THE VENIPUNCTURE. I ONLY HAVE 15 BOXES OF LOT 0248412, SO THEY MAY HAVE BEEN USING THEM FOR A WHILE. THEY HAVE BEEN REMOVED FROM USE. THE NEWER LOTS I CURRENTLY HAVE ARE 0260549 AND 0135002."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109121 BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 368607 0248412 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention