BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM

    MDR report key: 15419687 · Received September 14, 2022

    Report

    Report Number
    3006260740-2022-03606
    Event Type
    Malfunction
    Date Received
    September 14, 2022
    Date of Event
    August 25, 2022
    Report Date
    September 23, 2022
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741129650
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE; THE MANUFACTURING LOT NUMBER THAT WAS PROVIDED IS INCORRECT/INVALID. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED "CATHETER HAD A HOLE AND IT AND WAS LEAKING. PRODUCT WAS REMOVED. PATIENT HAD THE PICC SINCE 7/28" ADD INFO REC'D: DID EVENT OCCUR DURING PLACEMENT, WHILE IN USE ON A PATIENT, DURING REMOVAL, OR AFTER REMOVAL? DURING USE WAS A NEW DEVICE PLACED? NO. WAS THE DEVICE USED ON A PATIENT? YES ANY PATIENT HARM? UNKNOWN..

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "CATHETER HAD A HOLE AND IT AND WAS LEAKING. PRODUCT WAS REMOVED. PATIENT HAD THE PICC SINCE 7/28". ADDITIONAL INFORMATION RECEIVED: DID EVENT OCCUR DURING PLACEMENT, WHILE IN USE ON A PATIENT, DURING REMOVAL, OR AFTER REMOVAL? DURING USE. WAS A NEW DEVICE PLACED? NO. WAS THE DEVICE USED ON A PATIENT? YES. ANY PATIENT HARM? UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2745638 POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A REG3861(INVALID) 00801741129650

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other