BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER FLASHBACK BLOOD COLLECTION NEEDLE

    MDR report key: 10826192 · Received November 11, 2020

    Report

    Report Number
    8041187-2020-00725
    Event Type
    Injury
    Date Received
    November 11, 2020
    Date of Event
    October 22, 2020
    Report Date
    December 8, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: 11/3/2020 D.4. MEDICAL DEVICE LOT #: 0073711 D.4. MEDICAL DEVICE EXPIRATION DATE: 3/31/2022 H.4. DEVICE MANUFACTURE DATE: 4/1/2020 H.6. INVESTIGATION: BD RECEIVED 2 OPENED SAMPLES FROM THE CUSTOMER FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR LOOSE SHIELD WITH THE INCIDENT LOT WAS NOT OBSERVED. A SHIELD PULL FORCE TEST COULD NOT BE PERFORMED SINCE THE SAMPLES HAVE ALREADY BEEN OPENED. ONE OF THE SAMPLES SHOWED A DENT AND A HOOKED NEEDLE POINT WHICH COULD HAVE BEEN CAUSED BY OPENING THE SHIELD IN A BOW DIRECTION INSTEAD OF A STRAIGHT MOTION. 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 NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE LOOSE SHIELD. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE HAD THE "SHIELDS AND/OR PROTECTIVE CAP COMES OFF LETTING NEEDLE EXPOSED (APPLICABLE FOR PRODUCT PACKED BULK IN SHELF CARTONS) CLEAN NEEDLE STICK/INJURY AND NEEDLESTICK INJURY-POST USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED "WHEN THE BLOOD COLLECTION TEACHER USED A STRAIGHT NEEDLE TO COLLECT BLOOD, THE STRAIGHT NEEDLE UNSCREWED THE NP SHIELD AGAIN, AND THE IV SHIELD OPENED AUTOMATICALLY. SEVERAL TEACHERS IN THE CLINIC HAVE ENCOUNTERED THIS SITUATION MANY TIMES AND CAUSED THE BLOOD COLLECTION THE TEACHER HAS BEEN STABBED WITH STRAIGHT NEEDLES MANY TIMES AND THE BLOOD FLOW WILL NOT STOP, WHICH AFFECTS THE WORK AND WORKING MOOD, AND EXPRESSES THAT THERE IS A SERIOUS POTENTIAL RISK."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN ; DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE HAD THE 'SHIELDS AND/OR PROTECTIVE CAP COMES OFF LETTING NEEDLE EXPOSED (APPLICABLE FOR PRODUCT PACKED BULK IN SHELF CARTONS) CLEAN NEEDLE STICK/INJURY AND NEEDLESTICK INJURY-POST USE'., THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED, "WHEN THE BLOOD COLLECTION TEACHER USED A STRAIGHT NEEDLE TO COLLECT BLOOD, THE STRAIGHT NEEDLE UNSCREWED THE NP SHIELD AGAIN, AND THE IV SHIELD OPENED AUTOMATICALLY. SEVERAL TEACHERS IN THE CLINIC HAVE ENCOUNTERED THIS SITUATION MANY TIMES AND CAUSED THE BLOOD COLLECTION THE TEACHER HAS BEEN STABBED WITH STRAIGHT NEEDLES MANY TIMES AND THE BLOOD FLOW WILL NOT STOP, WHICH AFFECTS THE WORK AND WORKING MOOD, AND EXPRESSES THAT THERE IS A SERIOUS POTENTIAL RISK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286335 BD VACUTAINER FLASHBACK BLOOD COLLECTION NEEDLE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON MEDICAL (SINGAPORE) 0073711

    Patients

    Seq Age Sex Outcome Treatment
    1