BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERGROSHONG CATHETER WITH SHERLOCK TPS STYLET FULL KIT (5F) SL 45 CM

    MDR report key: 13419343 · Received February 1, 2022

    Report

    Report Number
    3006260740-2022-00126
    Event Type
    Injury
    Date Received
    February 1, 2022
    Date of Event
    January 7, 2022
    Report Date
    February 16, 2022
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    801(E)
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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) OF REFS0792 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE BLOOD DRAW PHASE, THERE IS A MALFUNCTION OF THE DEVICE, LEAKAGE OF THE WASHING LIQUID AND PAIN IN THE LIMB. THE REFERRING PHYSICIAN IS NOTIFIED, A CHEST X-RAY IS PERFORMED. THE EXECUTION OF THE X-RAY GAVE THE RESULT OF BREAKING THE PICC, THE PATIENT IS THEN SENT TO THE INTERVENTIONAL RADIOLOGY DEPARTMENT FOR TREATMENT OF THE CASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE BLOOD DRAW PHASE, THERE IS A MALFUNCTION OF THE DEVICE, LEAKAGE OF THE WASHING LIQUID AND PAIN IN THE LIMB. THE REFERRING PHYSICIAN IS NOTIFIED, A CHEST X-RAY IS PERFORMED. THE EXECUTION OF THE X-RAY GAVE THE RESULT OF BREAKING THE PICC, THE PATIENT IS THEN SENT TO THE INTERVENTIONAL RADIOLOGY DEPARTMENT FOR TREATMENT OF THE CASE. ADDITIONAL INFORMATION: ¿ WAS THE CATHETER RETAINED IN THE PATIENT? YES. ¿ IF HE WAS, DID HE MIGRATE? YES. ¿ WAS HE SUCCESSFULLY REMOVED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1212676 POWERGROSHONG CATHETER WITH SHERLOCK TPS STYLET FULL KIT (5F) SL 45 CM CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A REFS0792

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention