BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPORT ISP MRI 6CF INT W SP, ATT, SL

    MDR report key: 20935849 · Received December 15, 2024

    Report

    Report Number
    3006260740-2024-07480
    Event Type
    Malfunction
    Date Received
    December 15, 2024
    Date of Event
    November 20, 2024
    Report Date
    March 24, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJT
    PMA / PMN Number
    K063377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUESTED AS THE LOT NUMBER REPORTED IS UNKNOWN. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOS WERE PROVIDED FOR REVIEW. UPON REVIEWING THE INSTRUCTIONS FOR USE (IFU) OF THE DEVICE IN THE JDE, THE PROVIDED SPATIAL GRADIENT FIELD VALUE SEEMS TO BE CORRECT. NO OTHER ANOMALIES/ DISCREPANCIES WERE NOTED ON THE PROVIDED IFU. HOWEVER THE INVESTIGATION IS INCONCLUSIVE FOR REPORTED MISLABELED INSTRUCTION ISSUE AS IFU'S THAT REFERENCE A LOWER SPATIAL GRADIENT OF 330 GUASS/CM ARE NOT TECHNICALLY INCORRECT, AS 3000 GAUSS/CM IS ALSO WELL BELOW WHAT INTERNAL TESTING SUBSTANTIATES. MR CONDITIONAL INSERT RECOMMEND A MAXIMUM SPATIAL GRADIENT MAGNETIC FIELD OF 3,000 GAUSS/CM OR LESS FOR ALL PORTS. THEREFORE, IT IS REASONABLE TO SUGGEST THAT CONDUCTING AN MRI PROCEDURE ABOVE 330 AND BELOW 3000 WOULD ALIGN WITH A NEGLIGIBLE SEVERITY OF HARM. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTATION (E.G. PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) DID NOT FIND ANY PRODUCT LABELING INADEQUACY. H11: SECTION A THROUGH F: THE INFORMATION PROVIDE BY BD REPRESENTS ALL 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.

    Additional Manufacturer Narrative · 0

    H10: 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. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. 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

    IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT PROCEDURE, THE PATIENT INFORMATION FROM THE BD WEBSITE ALLEGEDLY STATES 3000 GAUSS/CM WHILE THE INSTRUCTION FOR USE STATES 330 GAUSS/CM. IT WAS FURTHER REPORTED THAT THE CUSTOMER WAS NOT SURE IF A PATIENT WITH A BD POWERPORT 8806060 COULD BE PUT IN THE MRI. ADDITIONALLY, THE CUSTOMER WAITED FOR AN OFFICIAL STATEMENT, WHICH WAS 3000 GAUSS/CM (MEDICAL SERVICES, (B)(4). THERE WAS NO PATIENT CONTACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT PROCEDURE, THE PATIENT INFORMATION FROM THE BD WEBSITE ALLEGEDLY STATES 3000 GAUSS/CM WHILE THE INSTRUCTION FOR USE STATES 330 GAUSS/CM. IT WAS FURTHER REPORTED THAT THE CUSTOMER WAS NOT SURE IF A PATIENT WITH A BD POWERPORT 8806060 COULD BE PUT IN THE MRI. ADDITIONALLY, THE CUSTOMER WAITED FOR AN OFFICIAL STATEMENT, WHICH WAS 3000 GAUSS/CM (MEDICAL SERVICES, BAW0736290). THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2381496 POWERPORT ISP MRI 6CF INT W SP, ATT, SL PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT C.R. BARD, INC. (BASD) -3006260740 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown