BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC SOLO CATHETER W/ SHERLOCK 3CG (TPS) STYLET 4F FULL TRAY

    MDR report key: 20153299 · Received September 5, 2024

    Report

    Report Number
    3006260740-2024-04953
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    August 14, 2024
    Report Date
    November 15, 2024
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    K091324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED PICC LINE FLUSHED WITH NACL. LEAKING NOTICED FROM EXIT SITE. INCIDENT OCCURRED DURING USE. PATIENT ATTENDED FACILITY FOR REPEAT FBP PRIOR TO SEEING DR, PICC LINE INSITU. PRIOR TO TAKING BLOOD PATIENT STATED THAT THE DISTRICT NURSES HAD EXPERIENCED ISSUES TAKING BLOOD AND WHILE FLUSHING THE PICC LINE THE DN'S AND PATIENT NOTICED OOZING/LEAKING FROM EXIT SITE, COVERED BY BIOPATCH. FBP TAKEN NO ISSUES, GOOD VENOUS RETURN. PICC DRESSING REMOVED, BIOPATCHED REMOVED, PICC LINE FLUSHED WITH NACL. LEAKING NOTICED FROM EXIT SITE. PATIENT DID NOT COMPLAIN OF ANY PAIN OR DISCOMFORT. BUT PATIENT DID STATE HE HAD EXPERIENCED PAIN WHEN THE DN'S WERE FLUSHING IT. THERE WAS A DELAY IN THE PATIENT'S TREATMENT. PICC REMOVED, PATIENT IS AWAITING NEW PICC PLACEMENT. SECURED WITH SECUREACATH. EXIT SITE MARKING 4CM. DRUG DETAILS: FLOT REGIMEN NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED PICC LINE FLUSHED WITH NACL. LEAKING NOTICED FROM EXIT SITE. INCIDENT OCCURRED DURING USE. PATIENT ATTENDED FACILITY FOR REPEAT FBP PRIOR TO SEEING DR, PICC LINE INSITU. PRIOR TO TAKING BLOOD PATIENT STATED THAT THE DISTRICT NURSES HAD EXPERIENCED ISSUES TAKING BLOOD AND WHILE FLUSHING THE PICC LINE THE DN'S AND PATIENT NOTICED OOZING/LEAKING FROM EXIT SITE, COVERED BY BIOPATCH. FBP TAKEN NO ISSUES, GOOD VENOUS RETURN. PICC DRESSING REMOVED, BIOPATCHED REMOVED, PICC LINE FLUSHED WITH NACL. LEAKING NOTICED FROM EXIT SITE. PATIENT DID NOT COMPLAIN OF ANY PAIN OR DISCOMFORT. BUT PATIENT DID STATE HE HAD EXPERIENCED PAIN WHEN THE DN'S WERE FLUSHING IT. THERE WAS A DELAY IN THE PATIENT'S TREATMENT. PICC REMOVED, PATIENT IS AWAITING NEW PICC PLACEMENT. SECURED WITH SECUREACATH. EXIT SITE MARKING 4CM. DRUG DETAILS: FLOT REGIMEN NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED AND ADDED TO FILE ON NOVEMBER 11, 2024 FOR THIS EVENT AS PART OF A FOCUS SURVEY. THE FOLLOWING ADDITIONAL DETAIL WAS PROVIDED: PLACED (B)(6) 2024 REMOVED (B)(6) 2024. TOTAL CATHETER LENGTH 48CM, PLACED IN BASILIC VEIN, EXIT SITE MARKING 3CM, SECURED WITH SECURACATH BETWEEN 1 AND 3CM. PICC USED FOR ONCOLOGY TREATMENT (OXALIPLATIN). NO OCCLUSIONS WITH THIS PICC. LEAKAGE FOUND AT 4CM INTERNALLY. PICC WAS USED 57 DAYS. NO XRAY IMAGING OF THE INCIDENT. CATHETER SITE CLEANED WITH CHLORAPREP (3ML 2% CHG IN 70% IPA). ADDITIONAL COMMENTS: TWO DAYS BEFORE IDENTIFIED THERE WERE ISSUES TAKING BLOODS IN THE COMMUNITY AND PATIENT REMEMBERS PICC LEAKING AT EXIT SITE. NOT OBVIOUS BECAUSE OF BIOPATCH IN PLACE, SEEN IN CLINIC AND DECIDED TO REMOVE AND FRACTURE SEEN. ONCO VAT ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1865509 POWERPICC SOLO CATHETER W/ SHERLOCK 3CG (TPS) STYLET 4F FULL TRAY CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A REHZ0408

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other