BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR PLASTIPAK 3ML 25X7 VETERINARY NBS

    MDR report key: 11067237 · Received December 23, 2020

    Report

    Report Number
    3003916417-2020-00368
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Date of Event
    November 25, 2020
    Report Date
    December 10, 2020
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE LOT #: THE CUSTOMER PROVIDED LOT #'S 9135960, 9073669, 9135964. THESE DO NOT MATCH THE CATALOG NUMBER PROVIDED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 9011870. MEDICAL DEVICE EXPIRATION DATE: 2024-01-31. DEVICE MANUFACTURE DATE: 2019-01-31. (B)(6). (B)(4). INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. INVESTIGATION CONCLUSION: 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. ROOT CAUSE DESCRIPTION: A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYR PLASTIPAK 3ML 25X7 VETERINARY NBS WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER CONTACTED CUSTOMER SERVICE CENTER AND SAID THAT AT THE TIME OF APPLICATION, IT WAS NOT POSSIBLE TO ASPIRATE THE SYRINGE SOLUTION, AS IF THE NEEDLE WAS CLOGGED OR THE PLUNGER WAS DEFECTIVE. THE APPLICATION WAS PERFORMED USING ANOTHER SYRINGE AND THE DEFECTIVE SYRINGE WAS DISCARDED. THE CUSTOMER DID NOT SEND THE DEFECTIVE SYRINGE, MAKING IT IMPOSSIBLE TO CONFIRM THE REPORT AND IDENTIFY WHICH SYRINGE BATCH HAD THE DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1527390 SYR PLASTIPAK 3ML 25X7 VETERINARY NBS SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1