BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 50 ML LUER-LOK¿

    MDR report key: 13981402 · Received April 1, 2022

    Report

    Report Number
    1911916-2022-00176
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    March 15, 2022
    Report Date
    June 22, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: IT WAS REPORTED SIXTEEN SYRINGES HAVE A HOLE OR CUT IN THE PACKAGES. TO AID IN THE INVESTIGATION, SIXTEEN SAMPLES AND THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. FIFTEEN OF THE SAMPLES CAME IN SEALED PACKAGING BLISTERS. A VISUAL INSPECTION WAS PERFORMED AND THE FIFTEEN SAMPLES HAVE THE PACKAGING TOP WEB CUT 1/16" LONG. EIGHT SAMPLES HAVE THE TOP WEB DAMAGED TOWARDS THE BOTTOM PART OF THE SYRINGE AND SEVEN SAMPLES TOWARDS THE TOP PART OF THE SYRINGE. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. IN THE PHOTOS PROVIDED, ONE PHOTO SHOWS SIXTEEN PACKAGING BLISTERS ON A TABLE. ANOTHER PHOTO SHOWS A PACKAGING BLISTER TOP WEB WITH A SMALL CUT AT THE BOTTOM WHERE THE WORD 'REF' IS. THE LAST PHOTO SHOWS ANOTHER PACKAGING BLISTER TOP WEB WITH A SMALL CUT WHERE THE UMBRELLA SYMBOL IS. THIS IS TOWARDS THE MIDDLE OF THE TOP WEB. THIS DEFECT COULD OCCUR WHEN OPENING THE PACKAGING BOXES. THERE ARE NO ELEMENTS DURING THE MANUFACTURING PROCESS THAT COULD INDUCE THIS TOP WEB DAMAGE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303552, LOT NUMBER 1103473. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. VERIFICATION OF THE PACKAGING PROCESS CONFIRMED THERE ARE NO TOOL OR ACCESSORIES THAT COULD CAUSE THE SYMPTOM REPORTED. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED, BUT A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 50 ML LUER-LOK¿ UNIT PACKAGING HAD A HOLE. THIS EVENT OCCURRED (B)(6) TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: 16 SYRINGES HAVE A HOLE(CUT) IN PACKAGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 16 BD SYRINGE 50 ML LUER-LOK¿ UNIT PACKAGING HAD A HOLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: 16 SYRINGES HAVE A HOLE(CUT) IN PACKAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1839151 BD SYRINGE 50 ML LUER-LOK¿ PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 1103473

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown