BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE ECLIPSE 21X1-1/2 RB TW

    MDR report key: 9983250 · Received April 21, 2020

    Report

    Report Number
    8041187-2020-00220
    Event Type
    Malfunction
    Date Received
    April 21, 2020
    Date of Event
    April 1, 2020
    Report Date
    April 30, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057659
    PMA / PMN Number
    K161170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO PHOTOS WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON VISUAL INSPECTION IT WAS OBSERVED THAT THERE WAS DAMAGE ON THE SEALING OF THE UNIT PACKAGE AND DAMAGE ON THE HUB COMPONENT; THEREFORE, THE INCIDENT COULD BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. THE SECONDARY PACKAGING PROCESS WAS REVIEWED. BASED ON THE PHOTO EVALUATION, THE DAMAGED OCCURS AT THE MIDDLE PRODUCT WITHIN THE STRIP. THE DAMAGE COULD HAVE HAPPENED DURING PRODUCT INSERTION TO THE SHELF CARTON. THERE ARE THREE GRIPPERS AT THE TOP AND BOTTOM TO GUIDE THE PRODUCT INTO THE SHELF CARTON. THE GRIPPER COULD HAVE BEEN BENT AND THEN WHERE THIS BENT GRIPPER EVENTUALLY HIT THE PART IT COULD HAVE CAUSED DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLES ECLIPSE 21X1-1/2 RB TW EXPERIENCED DAMAGED OR OPEN UNIT PACKAGING/SEAL WHERE STERILITY WAS COMPROMISED. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305765 BATCH NO.: 8171369, UNKNOWN WE RECEIVED 801,600 NEEDLES OF LOT 8171369. OUR PACKAGING LOTS ARE AROUND 100K , AND WE HAVE SEEN THIS DEFECT IN MORE THAN ONE LOT. NOT A LARGE NUMBER, WE DON'T KEEP TRACK OF HOW MANY. NO IMPACT, EASY TO SORT OUT. WE HAVE NOT BEEN CAPTURING THE NUMBER OF THE OTHER PACKAGING LOT DEFECTS. THE NUMBERS ARE SMALL, I WAS JUST LETTING YOU KNOW WE ARE STILL SEEING THE DEFECT. WE WILL IN THE FUTURE PROVIDE YOU FIRM NUMBERS FOR ANY DEFECTS WE FIND ON LINE. DAMAGED NEEDLE PACKS OPENED. DURING THE PACKAGING CL0537 ON (B)(6) 2020, NEEDLE 21 GAUGE 1 1/2" BD ECLIPSE (VENDOR LOT 8171369) 5 NEEDLE SLEEVES WERE NOTED TO HAVE DAMAGE TO THE NEEDLE AND THE TYVEK POUCH WAS OPENED. THE DEFECT IS SUCH THAT IT QUESTIONS THE STERILITY OF THE PRODUCT RECEIVED FROM BD.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8171369. MEDICAL DEVICE EXPIRATION DATE: 2023-06-30. DEVICE MANUFACTURE DATE: 2018-06-20. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLES ECLIPSE 21X1-1/2 RB TW EXPERIENCED DAMAGED OR OPEN UNIT PACKAGING/SEAL WHERE STERILITY WAS COMPROMISED. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305765, BATCH NO.: 8171369, UNKNOWN. WE RECEIVED 801,600 NEEDLES OF LOT 8171369. OUR PACKAGING LOTS ARE AROUND 100K , AND WE HAVE SEEN THIS DEFECT IN MORE THAN ONE LOT. NOT A LARGE NUMBER, WE DON'T KEEP TRACK OF HOW MANY. NO IMPACT, EASY TO SORT OUT. WE HAVE NOT BEEN CAPTURING THE NUMBER OF THE OTHER PACKAGING LOT DEFECTS. THE NUMBERS ARE SMALL, I WAS JUST LETTING YOU KNOW WE ARE STILL SEEING THE DEFECT. WE WILL IN THE FUTURE PROVIDE YOU FIRM NUMBERS FOR ANY DEFECTS WE FIND ON LINE. DAMAGED NEEDLE PACKS OPENED. DURING THE PACKAGING CL0537 ON (B)(6) 2020, NEEDLE 21 GAUGE 1 1/2" BD ECLIPSE (VENDOR LOT 8171369) 5 NEEDLE SLEEVES WERE NOTED TO HAVE DAMAGE TO THE NEEDLE AND THE TYVEK POUCH WAS OPENED. THE DEFECT IS SUCH THAT IT QUESTIONS THE STERILITY OF THE PRODUCT RECEIVED FROM BD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445337 NEEDLE ECLIPSE 21X1-1/2 RB TW HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 305765 SEE H.10 30382903057659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other