BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE 60 ML LUER SLIP TIP

    MDR report key: 13590687 · Received February 24, 2022

    Report

    Report Number
    1911916-2022-00102
    Event Type
    Malfunction
    Date Received
    February 24, 2022
    Date of Event
    February 11, 2022
    Report Date
    February 24, 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. 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

    H6: INVESTIGATION SUMMARY IT WAS REPORTED THE SYRINGE WAS RECEIVED WITHOUT THE GRADUATION SCALE. TO AID IN THE INVESTIGATION, ONE VIDEO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE VIDEO SHOWS A SYRINGE WITH NO SCALE MARKINGS. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR DURING THE SYRINGE BARREL PRINTING PROCESS INDUCING THE SYMPTOM REPORTED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302829, LOT NUMBER 9182654. 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 PRINTING PROCESS WAS PERFORMED. THE SETTINGS WERE CORRECT AND THE FLOW OF PRODUCTS WAS GOOD. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE VIDEO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SCALE MARKINGS WERE MISSING ON THE BD¿ SYRINGE 60 ML LUER SLIP TIP. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: SYRINGE 60ML WITHOUT GRADUATION IN ALL ITS EXTENSION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SCALE MARKINGS WERE MISSING ON THE BD¿ SYRINGE 60 ML LUER SLIP TIP. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: SYRINGE 60ML WITHOUT GRADUATION IN ALL ITS EXTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65498 BD¿ SYRINGE 60 ML LUER SLIP TIP PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 9182654

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown