BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ PROTECTOR P50

    MDR report key: 16376712 · Received February 15, 2023

    Report

    Report Number
    3003152976-2023-00026
    Event Type
    Malfunction
    Date Received
    February 15, 2023
    Date of Event
    January 19, 2023
    Report Date
    March 20, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    50382905151069
    PMA / PMN Number
    K123213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 03-FEB-2023. H6: INVESTIGATION SUMMARY THREE SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE PACKAGE SEAL WAS OBSERVED TO BE OPEN, VERIFYING THE REPORTED INCIDENT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2112114, FINDING A MAINTENANCE INTERVENTION WAS PERFORMED DURING MANUFACTURING AFTER PERSONNEL IDENTIFIED THE SEALING PATTERN WAS LOOSE. DEVICE RECORDS INDICATE THE MAINTENANCE WAS PERFORMED AS A PREVENTATIVE MEASURE AS NO DEFECTIVES PRODUCTS WERE ACTUALLY IDENTIFIED AT THE TIME IT WAS PERFORMED. RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PACKAGES WERE INSPECTED, THE SEALS WERE VERIFIED TO BE PROPERLY FORMED AND NO OPEN PACKAGED WERE FOUND. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. BASED ON OUR INVESTIGATION IT WAS DETERMINED THIS INCIDENT WAS RELATED TO AN ISSUE WITH THE SEALING GASKET THAT WAS REPLACED DURING MANUFACTURING, THE IMPACTED PRODUCTS NOT BEING PROPERLY IDENTIFIED AT THE TIME IT OCCURRED. A PROJECT HAS BEEN OPENED TO FURTHER ADDRESS THIS INCIDENT. H3 OTHER TEXT : SEE H10

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PHASEAL¿ PROTECTOR P50 THERE WAS PACKAGING DAMAGE. THIS OCCURRED 3 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT OPEN PACKAGES OF PROTECTOR. ACCORDING TO THE CUSTOMER'S REPORT, SEVERAL PACKAGES WERE FOUND TO BE PARTIALLY OPEN BEFORE USE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PHASEAL¿ PROTECTOR P50 THERE WAS PACKAGING DAMAGE. THIS OCCURRED 3 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT OPEN PACKAGES OF PROTECTOR. ACCORDING TO THE CUSTOMER'S REPORT, SEVERAL PACKAGES WERE FOUND TO BE PARTIALLY OPEN BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1290010 BD PHASEAL¿ PROTECTOR P50 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515106 2112114 50382905151069

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown