BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20097006 · Received August 29, 2024

    Report

    Report Number
    3006260740-2024-04848
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    July 31, 2024
    Report Date
    January 27, 2025
    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 MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. A SUPPLEMENTAL WILL BE SUBMITTED WITH EVALUATION RESULTS.

    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 COMPLAINT OF A LEAK IS CONFIRMED BUT THE CAUSE IS UNKNOWN. THE PRODUCT RETURNED FOR EVALUATION WAS A 4FR SL POWERPICC SOLO CATHETER. THE RETURNED PRODUCT SAMPLE WAS EVALUATED AND A KINK IMPRESSION WITH A LONGITUDINAL SPLIT WAS OBSERVED BETWEEN THE 5 AND 6CM MARK ON THE CATHETER BODY. THE CATHETER WAS FLATTENED BETWEEN THE 2CM AND 4CM MARKS. NO SPECIFIC EVIDENCE WAS SEEN DURING THE INVESTIGATION WHICH SUPPORTED A SPECIFIC ROOT CAUSE FOR THIS EVENT. THE DAMAGE LOCATION SUGGESTED THAT CATHETER SECUREMENT, ACCESS AND MAINTENANCE TECHNIQUES MAY HAVE CONTRIBUTED. AN EXAMINATION OF THE CATHETER STRUCTURE REVEALED NO POTENTIAL DAMAGE/DEFECT RELATED TO MANUFACTURE OF THE PRODUCT. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.

    Description of Event or Problem · 0

    IT WAS REPORTED STAFF NURSE WAS OBTAINING BLOODS FROM PICC LINE OF PATIENT. ON FLUSHING THE PICC LINE STAFF NURSE NOTICED LEAKING FLUID FROM THE PICC LINE. STAFF NURSE ALERTED NURSE-IN-CHARGE WHO THEN NOTIFIED NURSE LED PICC SERVICE. PICC LINE FRACTURE WAS OBSERVED BY STAFF AND THEN REMOVED AS FRACTURED. DOCTOR WAS INFORMED. PATIENT WAS CANNULATED FOR TODAYS CHEMO. PICC REMOVED AND NEW REFERRAL FOR PICC REQUIRED ADDITIONAL INFORMATION 08/22/2024: PATIENT ATTENDED SPU 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, BIOPATCH 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. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED STAFF NURSE WAS OBTAINING BLOODS FROM PICC LINE OF PATIENT. ON FLUSHING THE PICC LINE STAFF NURSE NOTICED LEAKING FLUID FROM THE PICC LINE. STAFF NURSE ALERTED NURSE-IN-CHARGE WHO THEN NOTIFIED NURSE LED PICC SERVICE. PICC LINE FRACTURE WAS OBSERVED BY STAFF AND THEN REMOVED AS FRACTURED. DOCTOR WAS INFORMED. PATIENT WAS CANNULATED FOR TODAYS CHEMO. PICC REMOVED AND NEW REFERRAL FOR PICC REQUIRED. ADDITIONAL INFORMATION 08/22/2024: PATIENT ATTENDED SPU 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, BIOPATCH 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. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1765543 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