BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTOR P55

    MDR report key: 8776824 · Received July 10, 2019

    Report

    Report Number
    3003152976-2019-00455
    Event Type
    Malfunction
    Date Received
    July 10, 2019
    Date of Event
    June 24, 2019
    Report Date
    August 29, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905151170
    PMA / PMN Number
    K130197
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: WE RECEIVED THREE PROTECTORS FOR EVALUATION ALONG WITH TWO L-CONNECTORS THAT WERE RETURNED WITH THE SAMPLES FOR THIS INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS OBSERVED ON THE PROTECTORS, THE PROTECTORS FIT SECURELY TO THE VIAL, AND THE NEEDLE ON THE PROTECTOR PENETRATED THE VIAL STOPPER PROPERLY. A DEVICE HISTORY REVIEW WAS PERFORMED FOR SUSPECTED LOTS 1901110 AND 1901122, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FRAGMENTATION TESTING WAS REVIEWED FOR THE REPORTED LOTS AND RESULTS WERE FOUND TO BE ACCEPTABLE. CAPA#688697 WAS INITIATED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 PROTECTOR P55 EXPERIENCED FOREIGN MATTER CONTAMINATION AND CORING IN THE VIAL OR FLUID PATH. PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ·CORING OCCURRED SOMETIMES WHEN PREPARING MEDICATION. THE PHARMACEUTICAL COMPANY COMMENTED THEY DIDN'T CHANGE THE MATERIAL OF RUBBER STOPPERS. ·ALSO CORING OCCURRED ON THE VIALS OF MEDICATION WHICH DIDN'T OCCUR BEFORE.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1901110, MEDICAL DEVICE EXPIRATION DATE: N/A, DEVICE MANUFACTURE DATE: 2019-01-11. MEDICAL DEVICE LOT #: 1901122, MEDICAL DEVICE EXPIRATION DATE: N/A, DEVICE MANUFACTURE DATE: 2019-01-11. 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 3 PROTECTOR P55 EXPERIENCED FOREIGN MATTER CONTAMINATION AND CORING IN THE VIAL OR FLUID PATH. PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CORING OCCURRED SOMETIMES WHEN PREPARING MEDICATION. THE PHARMACEUTICAL COMPANY COMMENTED THEY DIDN'T CHANGE THE MATERIAL OF RUBBER STOPPERS. ALSO CORING OCCURRED ON THE VIALS OF MEDICATION WHICH DIDN'T OCCUR BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572724 PROTECTOR P55 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. SEE H.10 00382905151170

    Patients

    Seq Age Sex Outcome Treatment
    1 Other