BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 13159828 · Received January 4, 2022

    Report

    Report Number
    1024879-2021-00895
    Event Type
    Malfunction
    Date Received
    January 4, 2022
    Date of Event
    December 9, 2021
    Report Date
    December 9, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FPA
    UDI-DI
    50382903673648
    PMA / PMN Number
    K153309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: CATALOG NUMBER: 367364. BATCH NUMBER: 1231017. ONE CUSTOMER PHOTO WAS RECEIVED FOR REVIEW AND ANALYSIS. THE PHOTO SHOWS 2 PBBCS DEVICES IN THEIR ORIGINAL PACKAGING WITH 1 PACKAGE APPEARING TO HAVE A PRINTING DEFECT WHERE THE RED ¿ MARK (INDICATING WHERE TO OPEN THE PACKAGE) WAS MISSING. THEREFORE, THIS COMPLAINT IS CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. BASED ON THE CUSTOMER PHOTO PROVIDED, THE ROOT CAUSE OF THE MISSING MARKING IS THAT THE TOP WEB OF THE BLISTER PACK WAS MISALIGNED FROM THE BOTTOM WEB, MORE SPECIFICALLY, THE TOP WEB WAS POSITIONED HIGHER UP THAN USUAL. THIS CAUSED THE RED MARKING TO BE CUT OFF WHEN THE INDIVIDUAL BLISTER PACKS WERE CUT OUT WITH THE CUTTING BLADE. FURTHERMORE, AS THE TOP WEB PAPER ROLL DEPLETES, THE WEIGHT CHANGES AND CAN CAUSE TRACKING ISSUES LEFT/RIGHT WHICH IS WHAT LED TO THE MISALIGNMENT OF THE TOP AND BOTTOM WEBS. FURTHER PROCESSING OF THIS PART OCCURRED AS THIS PART WAS INADVERTENTLY NOT DISCARDED BY A PACKAGING ASSOCIATE. AWARENESS OF THIS COMPLAINT HAS BEEN CREATED WITHIN THE QUALITY AND ENGINEERING DEPARTMENTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. NO.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET HAS BEEN FOUND MISSING LABEL INFORMATION. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT A PACKAGE PRINTING ISSUE OF WINGSET PBBCS. ACCORDING TO THE CUSTOMER'S REPORT, THE PACKAGE WAS DIFFERENT FROM USUAL, WITH A MISSING ¿ MARK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1270640 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE FPA BECTON, DICKINSON & CO., (BD) 367364 1231017 50382903673648

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown