BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 9481974 · Received December 17, 2019

    Report

    Report Number
    1911916-2019-01310
    Event Type
    Malfunction
    Date Received
    December 17, 2019
    Date of Event
    December 3, 2019
    Report Date
    December 4, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: 19 PHOTOS WERE PROVIDED. THEY SHOW A CASE BOX, CASE BOX LABEL, SHELF BOX, SHELF BOX LABEL. THE SHELF BOX HAS THE INFORMATION PRINTED IN ABOUT 30 DEGREES ANGLE. THE SHELF BOX SHOWS DAMAGES LIKE IT WAS EXPOSED TO A COMPRESSION FORCE INDUCING THE DAMAGE AND ALSO HAS TORN E A CORNER OF THE TOP FLAP. THIS WOULD HAVE HAPPENED DURING THE MULTIVAC PACKAGING PROCESS. THE BOTTOM WEB IS FORMED TO CREATE A KIND OF NEST AND THE PART IS PLACED IN THE "NEST". THEN THE TOP WEB IS PLACED, AND THE BLISTER IS SEALED. AFTER THAT GROUPS OF FIVE SEALED BLISTER ARE PLACED TOGETHER AND THEY ARE ALL TOGETHER ARE PLACED IN A SHELF BOX. THEN THE SHELF BOX IS CLOSED AND LABELED AND PLACED IN THE CASE BOX. IN THIS CASE, THE SHELF BOX WAS NOT PROPERLY PLACED IN THE CONVEYOR INDUCING THE DAMAGES AND ALSO INDUCING THE PRINTING IN ANGLE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR LOT # 9162864 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECTS DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: THIS WOULD HAVE HAPPENED DURING THE MULTIVAC PACKAGING PROCESS. THE BOTTOM WEB IS FORMED TO CREATE A KIND OF NEST AND THE PART IS PLACED IN THE "NEST". THEN THE TOP WEB IS PLACED, AND THE BLISTER IS SEALED. AFTER THAT GROUPS OF FIVE SEALED BLISTER ARE PLACED TOGETHER UNTIL COMPLETING 20 OF THEM FROM THERE, THEY ALL TOGETHER ARE PLACED IN A SHELF BOX, THEN THE SHELF BOX IS CLOSED AND LABELED AND PLACED IN THE CASE BOX. IN THIS CASE, THE SHELF BOX WAS NOT PROPERLY PLACED IN THE CONVEYOR INDUCING THE DAMAGES WHILE PLACING IT IN THE CASE BOX; ALSO INDUCING THE PRINTING IN ANGLE. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE HAS BEEN FOUND EXPERIENCING TWO OCCURRENCES OF MISSING LABEL INFORMATION BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: TORE BOX AND DENTED = 12 SP / NO LOT = 2 SP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279850 BD PRECISIONGLIDE¿ NEEDLE NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 9162864

    Patients

    Seq Age Sex Outcome Treatment
    1 Other