BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD PICC

    MDR report key: 12911109 · Received December 1, 2021

    Report

    Report Number
    3006260740-2021-05094
    Event Type
    Injury
    Date Received
    December 1, 2021
    Date of Event
    November 10, 2021
    Report Date
    November 17, 2021
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "LINE WAS INSERTED LAST WEEK ON (B)(6) 2021 AND TIP WAS CONFIRMED WITH 3CG TECHNOLOGY. WE DON¿T ROUTINELY ORDER CXR FOR PICC INSERTIONS, UNLESS ITS CLINICALLY INDICATED. TODAY ((B)(6) 2021) THIS PATIENT REQUIRED A CXR AS PART OF THEIR ONGOING CARE AND THE TIP OF THE PICC LINE WAS SEEN IN THE IJ. THIS IS PARTICULARLY CONCERNING BECAUSE THE PATIENT WAS RECEIVING INFUSIONAL CHEMOTHERAPY VIA CADD PUMP AND HAS BEEN SUFFERING NEUROLOGICAL SYMPTOMS, POSSIBLY AS A RESULT OF THIS ERROR. THE PATIENT HAS ALSO RECEIVED IVAB AND ONGOING IVF SINCE THE PICC WAS INSERTED. THE TREATING HAEMATOLOGIST IS AWARE, AND A DECISION WAS MADE TO PULL THE LINE BACK TO THE SUBCLAVIAN VEIN FOR NOW. I WILL DO AN IIMS TODAY. REP HAVE REVIEWED THE ECG TIP CONFIRMATION FROM INSERTION AND THE P WAVE DEFINITELY LOOKS PEAKED TO ME. PICC MAY VERY WELL HAVE BEEN CORRECTLY PLACED ON INSERTION BUT MOVED BECAUSE OF INAPPROPRIATE FLUSHING, POWER INJECTION OR PATIENT FACTORS. CNC TO DISCUSS." 3CG USED IS (B)(4): SHERLOCK 3CG TCS D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1806959 BARD PICC CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention