BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4 FR SL POWER PICC SOSLO WITH TLS, MAXIMAL BARRIER PRECAUT

    MDR report key: 2993836 · Received March 4, 2013

    Report

    Report Number
    3006260740-2013-00098
    Event Type
    Injury
    Date Received
    March 4, 2013
    Report Date
    February 8, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K053501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR AT THIS TIME FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REWJ1639 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    PT NEEDED A CATHETER PLACED FOR A 2-3 WEEK PENICILLIN TREATMENT, WHILE THE CATHETER WAS BEING INSERTED THE GUIDEWIRE MALFUNCTIONED AND CAME APART, COMING TO A STOP ON THE WAY IN. THE TECHNICIAN/DOCTORS THEN TRIED TO PULL OUT THE WIRE WITH NO LUCK EITHER (WAS ONCE AGAIN STUCK). AFTER SOME EVALUATION AND X-RAYS, A SURGEON HAD TO PERFORM A RISKY PROCEDURE TO CUT INTO PT'S ARM TO FIND A WAY TO REMOVE THE BAD GUIDEWIRE. THIS EVENTUALLY LED TO MUCH PAIN AND SORENESS IN PT'S RIGHT ARM, FURTHER COMPLICATING HIS CONDITION AND DELAYING RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91626 4 FR SL POWER PICC SOSLO WITH TLS, MAXIMAL BARRIER PRECAUT LJS C. R. BARD INC. (BASD) REWJ1639

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention