BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TUBE PMS PLH 13X75 3.0 SLBL LIM CE

    MDR report key: 17390378 · Received July 25, 2023

    Report

    Report Number
    9617032-2023-00959
    Event Type
    Malfunction
    Date Received
    July 25, 2023
    Date of Event
    June 29, 2023
    Report Date
    July 24, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL/CORRECTED INFORMATION: D.1. MEDICAL DEVICE LOT #2192117.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 20 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO UNDERFILL AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE UNDERFILL. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD TUBE PMS PLH 13X75 3.0 SLBL LIM CE CUSTOMER STATES THAT PROBLEM WITH THE FILLING OF BARRICOR TUBES. THIS EVENT OCCURRED 5 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ON 29/06, WE RECEIVED AN E-MAIL FROM THE EMERGENCY DEPARTMENT ALERTING US TO A PROBLEM WITH THE FILLING OF BARRICOR TUBES. IT SEEMS THAT THESE TUBES ARE NOT FILLING UP TO THE MARK. THE EXPIRATION DATE IS NOVEMBER 2023, BATCH NUMBER: 2192117. HOWEVER, THIS IS NOT THE ONLY DEPARTMENT TO SEND US TUBES THAT ARE INSUFFICIENTLY FILLED. WE HAVE AT LEAST 4 NON-CONFORMITIES ON OUR QUALITY MANAGEMENT SOFTWARE WITH DEPARTMENTS SUCH AS GERIATRICS, PEDIATRICS AND CARDIOLOGY. IF THERE'S NO REACTION TO THIS BATCH OF TUBES, COULDN'T WE CONSIDER RAISING AWARENESS OF GOOD PRACTICE IN THE DEPARTMENTS, AND WORKING WITH THEM TO FIND OUT WHY THE TUBES AREN'T BEING FILLED CORRECTLY?

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD TUBE PMS PLH 13X75 3.0 SLBL LIM CE CUSTOMER STATES THAT PROBLEM WITH THE FILLING OF BARRICOR TUBES. THIS EVENT OCCURRED 5 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ON (B)(6), WE RECEIVED AN E-MAIL FROM THE EMERGENCY DEPARTMENT ALERTING US TO A PROBLEM WITH THE FILLING OF BARRICOR TUBES. IT SEEMS THAT THESE TUBES ARE NOT FILLING UP TO THE MARK. THE EXPIRATION DATE IS NOVEMBER 2023, BATCH NUMBER: 2192117. HOWEVER, THIS IS NOT THE ONLY DEPARTMENT TO SEND US TUBES THAT ARE INSUFFICIENTLY FILLED. WE HAVE AT LEAST 4 NON-CONFORMITIES ON OUR QUALITY MANAGEMENT SOFTWARE WITH DEPARTMENTS SUCH AS GERIATRICS, PEDIATRICS AND CARDIOLOGY.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD TUBE PMS PLH 13X75 3.0 SLBL LIM CE CUSTOMER STATES THAT PROBLEM WITH THE FILLING OF BARRICOR TUBES. THIS EVENT OCCURRED 5 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ON 29/06, WE RECEIVED AN E-MAIL FROM THE EMERGENCY DEPARTMENT ALERTING US TO A PROBLEM WITH THE FILLING OF BARRICOR TUBES. IT SEEMS THAT THESE TUBES ARE NOT FILLING UP TO THE MARK. THE EXPIRATION DATE IS NOVEMBER 2023, BATCH NUMBER: 2192117. HOWEVER, THIS IS NOT THE ONLY DEPARTMENT TO SEND US TUBES THAT ARE INSUFFICIENTLY FILLED. WE HAVE AT LEAST 4 NON-CONFORMITIES ON OUR QUALITY MANAGEMENT SOFTWARE WITH DEPARTMENTS SUCH AS GERIATRICS, PEDIATRICS AND CARDIOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1635085 BD TUBE PMS PLH 13X75 3.0 SLBL LIM CE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2192117

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown