BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4F SL POWERPICC 3CG MB

    MDR report key: 6746771 · Received July 27, 2017

    Report

    Report Number
    3006260740-2017-01143
    Event Type
    Malfunction
    Date Received
    July 27, 2017
    Report Date
    August 18, 2017
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741105173
    PMA / PMN Number
    K091324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: INITIAL MEDWATCH WAS SUBMITTED AS A SECOND EVENT, UPON FURTHER INFORMATION IT WAS FOUND THAT THIS MEDWATCH 3006260740-2017-01143 IS A DUPLICATE FILE AND HAS BEEN VOIDED. THE EVENT AND INVESTIGATION RESULTS HAVE BEEN SUBMITTED ON MEDWATCH 3006260740-2017-01107.

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD 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 BARD. THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF REAZ1009 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    FACILITY REPORTED PICC WAS PLACED ON (B)(6) 2017, IN THE RIGHT BASILIC VEIN. PICC WAS VERIFIED WITH CHEST X-RAY DUE TO ONSET AFIB. TIP WAS SEEN TO BE AT THE MID-LOWER SVC (2-3 CM ABOVE CAJ). NURSE WAS CALLED ON DAY 7 STATING PICC HAS HAD INTERMITTENT PROBLEMS AND HAD BEEN CATHFLOED TWO TIMES. ON DAY 7 THE PICC COMPLETELY STOPPED WORKING. CHEST X-RAY WAS DONE AND PICC WAS PROXIMAL SVC, 8 CM FROM CAJ. ORIGINAL DRESSING WAS INTACT AND PICC REMAINED 0 CM OUT. PICC WAS REPLACED ON (B)(6) 2017.

    Description of Event or Problem · 1

    FACILITY REPORTED PICC WAS PLACED ON (B)(6) 2017, IN THE RIGHT BASILIC VEIN. PICC WAS VERIFIED WITH CHEST X-RAY DUE TO ONSET AFIB. TIP WAS SEEN TO BE AT THE MID-LOWER SVC (2-3 CM ABOVE CAJ). NURSE WAS CALLED ON DAY 7 STATING PICC HAS HAD INTERMITTENT PROBLEMS AND HAD BEEN CATHFLOWED TWO TIMES. ON DAY 7 THE PICC COMPLETELY STOPPED WORKING. CHEST X-RAY WAS DONE AND PICC WAS PROXIMAL SVC, 8 CM FROM CAJ. ORIGINAL DRESSING WAS INTACT AND PICC REMAINED 0 CM OUT. PICC WAS REPLACED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526548 4F SL POWERPICC 3CG MB PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER LJS BARD ACCESS SYSTEMS CK000537 REAZ1009 00801741105173

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR