BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERPORT ISP IMPLANTABLE PORT

    MDR report key: 15481177 · Received September 24, 2022

    Report

    Report Number
    3006260740-2022-03719
    Event Type
    Injury
    Date Received
    September 24, 2022
    Date of Event
    August 25, 2022
    Report Date
    November 9, 2022
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJT
    PMA / PMN Number
    K063377
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE.

    Additional Manufacturer Narrative · 0

    H10: THE EVENT REPORTED IN THE INITIAL MFR REPORT # 3006260740-2022-03719 WAS FOR THE REPORTED EVENT OF OTHER UNSPECIFIED COMPLICATIONS. FOLLOWING DISCUSSION WITH FDA MDR LEADERSHIP, ONE MDR WILL BE FILED PER EVENT; THEREFORE, THE EVENT OF OTHER UNSPECIFIED COMPLICATIONS HAS BEEN CORRECTED IN MFR REPORT #3006260740-2022-04548 H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION , THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    THE FOLLOWING ADVERSE EVENTS WERE IDENTIFIED IN A STUDY UTILIZING ELECTRONIC HEALTH RECORD DATA PROVIDED BY MAYO CLINIC TO BD FOR THE PURPOSE OF EVALUATING CLINICAL OUTCOMES FOR BARDTM LONG-TERM IMPLANTABLE PORTS (POWER AND NON-POWER) USED IN A CONTEMPORARY REAL-WORLD COHORT OF PATIENTS. THIS MDR WILL CAPTURE THE UNKNOWN COMPLICATIONS REPORTED IN 7 PATIENTS DURING THE USE OF THE POWERPORT ISP IMPLANTABLE PORT PRODUCT (UNKNOWN PRODUCT CODE). EVENTS RANGE IN DATES FROM JUNE 17, 2017-JULY 26, 2021. POTENTIAL DEVICE-RELATED ADVERSE EVENTS WERE DETECTED USING THE PRESENCE OF DIAGNOSIS AND PROCEDURE CODES OCCURRING ON THE DATE OF PORT-IMPLANT OR UP TO THE DATE OF A TERMINAL EVENT. TO ENSURE PRIVACY, THE DATA HAVE UNDERGONE STATISTICAL ANONYMIZATION TO PRECLUDE REIDENTIFICATION WITH HIGH PROBABILITY. THIS DE-IDENTIFICATION PROCESS INCLUDES ALL DATES AND TIMES, WHICH ARE RANDOMLY ADJUSTED. THEREFORE, ANY INDIVIDUAL PROCEDURE, PATIENT OR EVENT INFORMATION IS NOT AVAILABLE. NO PART OR LOT NUMBERS ARE AVAILABLE AND NO DEVICES WERE RETURNED FOR EVALUATION AT THE TIME OF THE STUDY. NO ADDITIONAL INFORMATION REGARDING THESE EVENTS IS AVAILABLE.

    Description of Event or Problem · 0

    THIS COMPLAINT WILL CONTAIN INFECTION EVENTS IDENTIFIED IN THE RETROSPECTIVE MULTI-CENTRE ANALYSIS OF BD PORT IMPLANTS USING MAYO CLINIC EHRS DRAFTED BY GLOBAL CLINICAL AFFAIRS FOR PRODUCT FAMILY POWERPORT ISP IMPLANTABLE PORT (UNKNOWN PRODUCT CODE). THIS REPORT WAS GENERATED TO CAPTURE THE USE OF DATA PROVIDED BY MAYO CLINIC TO BD FOR THE PURPOSE OF EVALUATING CLINICAL OUTCOMES FOR BARDTM LONG-TERM IMPLANTABLE PORTS (POWER AND NON-POWER) USED IN A CONTEMPORARY REAL-WORLD COHORT OF PATIENTS. EVENTS RANGE IN DATES FROM JUNE 17, 2017-JULY 26, 2021. POTENTIAL DEVICE-RELATED ADVERSE EVENTS WERE DETECTED USING THE PRESENCE OF DIAGNOSIS AND PROCEDURE CODES OCCURRING ON THE DATE OF PORT-IMPLANT OR UP TO THE DATE OF A TERMINAL EVENT. TO ENSURE PRIVACY, THE DATA HAVE UNDERGONE STATISTICAL ANONYMIZATION TO PRECLUDE REIDENTIFICATION WITH HIGH PROBABILITY. THIS DE-IDENTIFICATION PROCESS INCLUDES ALL DATES AND TIMES, WHICH ARE RANDOMLY ADJUSTED. THEREFORE, ANY INDIVIDUAL PROCEDURE, PATIENT OR EVENT INFORMATION IS NOT AVAILABLE. NO PART OR LOT NUMBERS ARE AVAILABLE AND NO DEVICES WERE RETURNED FOR EVALUATION AT THE TIME OF THE STUDY. NO ADDITIONAL INFORMATION REGARDING THESE EVENTS ARE AVAILABLE. THE FOLLOWING ADVERSE EVENTS WERE IDENTIFIED IN THE REPORT FOR PRODUCT POWERPORT ISP IMPLANTABLE PORT (UNKNOWN PRODUCT CODE): INFECTION IN 2 PATIENTS, ARRHYTHMIA IN 8 PATIENTS, PNEUMOTHORAX IN 1 PATIENTS, PHLEBITIS IN 1 PATIENTS, OTHER UNKNOWN COMPLICATIONS IN 7 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2579495 POWERPORT ISP IMPLANTABLE PORT IMPLANTABLE PORT LJT C.R. BARD, INC. (BASD) -3006260740 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening