BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS SYR PSD MICROBORE

    MDR report key: 10251975 · Received July 9, 2020

    Report

    Report Number
    9616066-2020-02136
    Event Type
    Malfunction
    Date Received
    July 9, 2020
    Date of Event
    June 19, 2020
    Report Date
    June 19, 2020
    Manufacturer
    CFN MEXICO 215 SA DE CV
    Product Code
    FPA
    UDI-DI
    10885403233906
    PMA / PMN Number
    K811885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PHOTO OF THE CRACKED SYRINGE WAS RECEIVED BY THE QUALITY TEAM FOR EVALUATION. FROM THE PHOTO PROVIDED, IT WAS OBSERVED THAT THERE WAS A CRACK AT THE NEEDLE ADAPTER LOCATION OF THE SYRINGE. A DEVICE HISTORY RECORD REVIEW FOR MODEL 10014914 WITH A LOT NUMBER OF 20015853 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS FOR WAS BUILT ON 10JAN2020. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THESE SETS. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-01-10. D.4. MEDICAL DEVICE LOT #: 20015853. H.4. DEVICE MANUFACTURE DATE: 2020-01-10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AS SYR PSD MICROBORE TUBING CRACKED AND THE BLOOD BACKED UP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10014914 BATCH NO: UNKNOWN. IT WAS REPORTED MORPHINE TUBING CRACKED AT THE CLAVE. " MORPHINE TUBING CRACKED AT CLAVE. BLOOD BACKED UP TO MORPHINE SYRINGE. TUBING DISCONNECTED STERILELY WITH 2 RNS. NEW TUBING RECONNECTED STERILELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AS SYR PSD MICROBORE TUBING CRACKED AND THE BLOOD BACKED UP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10014914 BATCH NO: UNKNOWN. IT WAS REPORTED MORPHINE TUBING CRACKED AT THE CLAVE. " MORPHINE TUBING CRACKED AT CLAVE. BLOOD BACKED UP TO MORPHINE SYRINGE. TUBING DISCONNECTED STERILELY WITH 2 RNS. NEW TUBING RECONNECTED STERILELY.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS SYR PSD MICROBORE TUBING CRACKED AND THE BLOOD BACKED UP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10014914 , BATCH NO: UNKNOWN. IT WAS REPORTED MORPHINE TUBING CRACKED AT THE CLAVE. "MORPHINE TUBING CRACKED AT CLAVE. BLOOD BACKED UP TO MORPHINE SYRINGE. TUBING DISCONNECTED STERILELY WITH 2 RNS. NEW TUBING RECONNECTED STERILELY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717547 AS SYR PSD MICROBORE INTRAVASCULAR ADMINISTRATION SET FPA CFN MEXICO 215 SA DE CV 10014914 20015853 10885403233906

    Patients

    Seq Age Sex Outcome Treatment
    1 Other