BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19555012 · Received June 17, 2024

    Report

    Report Number
    3006260740-2024-03060
    Event Type
    Injury
    Date Received
    June 17, 2024
    Date of Event
    April 24, 2024
    Report Date
    May 23, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    K091324
    Removal / Correction Number
    MDS-24-5154-C
    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

    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. THE COMPLAINT OF A DAMAGED CATHETER WAS CONFIRMED AND WAS DETERMINED TO BE USE RELATED. THE PRODUCT RETURNED FOR EVALUATION WAS A 4FR SINGLE LUMEN POWERPICC CATHETER. THE INVESTIGATION FINDINGS ARE CONSISTENT WITH DAMAGE ACCUMULATED THROUGH FLEXURAL FATIGUE. FLEXURAL FATIGUE OCCURS DUE TO CYCLIC KINKING OF THE CATHETER TUBE IN WHICH PHYSIOLOGICAL, PLACEMENT, USAGE, AND MECHANICAL FACTORS MAY GRADUALLY FORM A CRACK(S) IN THE CATHETER. THE RETURNED PRODUCT SAMPLE WAS EVALUATED AND TWO SPLITS WERE OBSERVED AT THE 6CM DEPTH MARKING. ONE OF THE SPLITS WERE CIRCUMFERENTIALLY ALIGNED AND THE OTHER SPLIT WAS LONGITUDINALLY ALIGNED. THE CATHETER SPLITS CONTAINED PHYSICAL FEATURES ASSOCIATED WITH MATERIAL FATIGUE, AND THE CHARACTERISTICS OBSERVED WHICH SUPPORTED THIS TYPE OF FAILURE INCLUDED: ¿ DAMAGE WHICH WAS CIRCUMFERENTIALLY ALIGNED. ¿ FRACTURE EDGES WHICH WERE ROUNDED AND POLISHED DUE TO REPEATED MATERIAL WEAR. 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 MIDWAY OF THE SUMMONS OF OXALIPLATIN GTA, THE PATIENT REPORTED SWELLING OF THE RIGHT UPPER LIMB, WHICH HOUSED THE PICC, AND SLIGHT OOZING OF FLUID FROM THE INSERTION SITE. UPON REMOVAL OF THE PICC, THERE WAS FISSURING OF THE SAME AT THE SIXTH CENTIMETRE. THE PATIENT SUBSEQUENTLY DEVELOPED THROMBOSIS WITH SUBSEQUENT WORSENING OF REDNESS, OEDEMA AND MOBILITY OF THE LIMB INTERESTED. THE PATIENT, AS A RESULT OF THE SPILLAGE OF THE DRUG DUE TO THE FISSURATION OF THE PICC, IS UNDER TREATMENT, AS PER COMPANY PROCEDURE, FOR THE PREVENTION AND TREATMENT OF EXTRAVASATION. TO DATE, AT THE 26TH DAY OF FOLLOW-UP THE THROMBOSIS IS BEING TREATED, THERE IS IMPROVEMENT IN THE REDNESS AND OEDEMA. ON THE OTHER HAND, THE MOBILITY OF THE LIMB IS STABLE AND THE PAIN, FOR WHICH HE IS FOLLOWED BY PAIN THERAPISTS. ADDITIONAL INFORMATION: UNFORTUNATELY THERE WERE NEGATIVE CONSEQUENCES FOR THE PATIENT. THE RUPTURE OF THE PICC IN QUESTION HAD CAUSED A MASSIVE OVERFLOW OF CHEMOTHERAPY DRUG (OXALIPLATIN). THE PATIENT HAD TO STOP THE INFUSION OF THERAPY AND ALL PROCEDURES FOR MANAGING THE OVERFLOW WERE IMPLEMENTED IN THE SAME WAY AS IN THE COMPANY OPERATIONAL INSTRUCTION. THE PATIENT HAD A SWOLLEN, WARM RIGHT LIMB WITH LIMITED MOTILITY FOR A PERIOD OF ABOUT A MONTH. TO DATE, THE PATIENT SHOWS IMPROVEMENT IN OEDEMA AND REDDENING OF THE SKIN, BUT LIMITED MOBILITY PERSISTS DUE TO THE FORMATION OF SCAR TISSUE FROM THE BICEPS TO LATER AT THE ELBOW. THIS TISSUE IS A CONSEQUENCE OF THE EXTRAVASATION THAT OCCURRED. THE HEALTHCARE PERSONNEL WERE EXPOSED TO BOTH BLOOD AND THE CHEMOTHERAPY DRUG, BUT WERE IN POSSESSION OF ALL THE PPE REQUIRED BY OUR COMPANY OPERATIONAL INSTRUCTION TO AVOID CONTAMINATION. FOLLOW-UP WAS UNDERTAKEN TO MONITOR THE OVERFLOW, THE SAME AS IN THE APPROPRIATE COMPANY PROCEDURE. IN ADDITION, THE PATIENT HAS BEEN SEEN BY PHYSIATRISTS IN ORDER TO SOFTEN THE SCAR TISSUE AND REGAIN SOME LIMB MOBILITY. THE PATIENT IS CURRENTLY BEING TREATED BY PAIN THERAPY SPECIALISTS.

    Description of Event or Problem · 0

    IT WAS REPORTED MIDWAY OF THE SUMMONS OF OXALIPLATIN GTA, THE PATIENT REPORTED SWELLING OF THE RIGHT UPPER LIMB, WHICH HOUSED THE PICC, AND SLIGHT OOZING OF FLUID FROM THE INSERTION SITE. UPON REMOVAL OF THE PICC, THERE WAS FISSURING OF THE SAME AT THE SIXTH CENTIMETRE. THE PATIENT SUBSEQUENTLY DEVELOPED THROMBOSIS WITH SUBSEQUENT WORSENING OF REDNESS, OEDEMA AND MOBILITY OF THE LIMB INTERESTED. THE PATIENT, AS A RESULT OF THE SPILLAGE OF THE DRUG DUE TO THE FISSURATION OF THE PICC, IS UNDER TREATMENT, AS PER COMPANY PROCEDURE, FOR THE PREVENTION AND TREATMENT OF EXTRAVASATION. TO DATE, AT THE (B)(6) DAY OF FOLLOW-UP THE THROMBOSIS IS BEING TREATED, THERE IS IMPROVEMENT IN THE REDNESS AND OEDEMA. ON THE OTHER HAND, THE MOBILITY OF THE LIMB IS STABLE AND THE PAIN, FOR WHICH HE IS FOLLOWED BY PAIN THERAPISTS. ADDITIONAL INFORMATION: UNFORTUNATELY, THERE WERE NEGATIVE CONSEQUENCES FOR THE PATIENT. THE RUPTURE OF THE PICC IN QUESTION HAD CAUSED A MASSIVE OVERFLOW OF CHEMOTHERAPY DRUG (OXALIPLATIN). THE PATIENT HAD TO STOP THE INFUSION OF THERAPY AND ALL PROCEDURES FOR MANAGING THE OVERFLOW WERE IMPLEMENTED IN THE SAME WAY AS IN THE COMPANY OPERATIONAL INSTRUCTION. THE PATIENT HAD A SWOLLEN, WARM RIGHT LIMB WITH LIMITED MOTILITY FOR A PERIOD OF ABOUT A MONTH. TO DATE, THE PATIENT SHOWS IMPROVEMENT IN OEDEMA AND REDDENING OF THE SKIN, BUT LIMITED MOBILITY PERSISTS DUE TO THE FORMATION OF SCAR TISSUE FROM THE BICEPS TO LATER AT THE ELBOW. THIS TISSUE IS A CONSEQUENCE OF THE EXTRAVASATION THAT OCCURRED. THE HEALTHCARE PERSONNEL WERE EXPOSED TO BOTH BLOOD AND THE CHEMOTHERAPY DRUG BUT WERE IN POSSESSION OF ALL THE PPE REQUIRED BY OUR COMPANY OPERATIONAL INSTRUCTION TO AVOID CONTAMINATION. FOLLOW-UP WAS UNDERTAKEN TO MONITOR THE OVERFLOW, THE SAME AS IN THE APPROPRIATE COMPANY PROCEDURE. IN ADDITION, THE PATIENT HAS BEEN SEEN BY PHYSIATRISTS IN ORDER TO SOFTEN THE SCAR TISSUE AND REGAIN SOME LIMB MOBILITY. THE PATIENT IS CURRENTLY BEING TREATED BY PAIN THERAPY SPECIALISTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332430 POWERPICC 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 REHT2245

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Unknown Required Intervention