BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL

    MDR report key: 9168032 · Received October 8, 2019

    Report

    Report Number
    9614033-2019-00252
    Event Type
    Malfunction
    Date Received
    October 8, 2019
    Date of Event
    September 10, 2019
    Report Date
    December 12, 2019
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE SAMPLE AND PHOTO RECEIVED FOR INVESTIGATION. UPON OBSERVATION, A HAIR CAN BE SEEN BETWEEN THE SEAL AND THE BLISTER PAPER. POSSIBLE ROOT CAUSE IS FAILURE IN THE DRESS PROCEDURE BY OPERATIONAL PERSONNEL. CORRECTIVE AND PREVENTATIVE ACTION (CAPA (B)(4)) WAS OPENED TO INVESTIGATE FOREIGN MATTER. AS A COMPLEMENT TO THIS ACTION, RETRAINING FOR OPERATIONAL PERSONNEL WAS CARRIED OUT, AN IT IS IMPORTANT TO MENTION THAT THE LOT WAS MANUFACTURED PRIOR TO THIS RETRAINING. FURTHERMORE, THE LOT WAS INSPECTED ACCORDING TO THE CURRENT WORK INSTRUCTION WITH SATISFACTORY RESULTS FOR THE CHARACTERISTICS REQUIRED FOR ITS APPROVAL INCLUDING FUNCTIONAL TESTS. NO NON-CONFORMING PART THAT COULD BE ATTRIBUTABLE TO THE DEFECT REPORTED BY THE CLIENT WAS PRESENTED. NO DEVIATIONS (QUALITY NOTIFICATIONS) WERE REPORTED DURING THE MANUFACTURING PROCESS. 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.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HAIR WAS NOTICED IN THE SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: "SYRINGE WITH HAIR."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HAIR WAS NOTICED IN THE SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: "SYRINGE WITH HAIR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963752 SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL SYRINGE FMF BECTON DICKINSON DE MEXICO 9048608

    Patients

    Seq Age Sex Outcome Treatment
    1 Other