BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC SOLO CATHETER, 5F TL, TT, 3CG

    MDR report key: 7589155 · Received June 11, 2018

    Report

    Report Number
    3006260740-2018-01325
    Event Type
    Malfunction
    Date Received
    June 11, 2018
    Report Date
    July 30, 2018
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741137679
    PMA / PMN Number
    K072230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD 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 BARD. THE MANUFACTURER HAS RECEIVED A PHOTO SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF REBN1525 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS RECEIVED A PHOTO SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF REBN1525 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, FREQUENCY ANALYSIS, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), APPLICABLE FMEA DOCUMENTS, LABELING, AND APPLICABLE MANUFACTURE RECORDS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A CRACKED HUB IS CONFIRMED TO BE MANUFACTURING RELATED. TWO PHOTO SAMPLES WERE RETURNED TO VAD FOR OBSERVATION. ONE PHOTO CONSISTED OF A SYRINGE ATTACHED TO A GREY AND BLUE SOLO HUB. A LONGITUDINAL CRACK WAS OBSERVED TO EXTEND FROM THE PROXIMAL END OF THE LUER DOWN TO THE ¿NO CT¿ LETTERS IN THE GREY PORTION OF THE HUB. THE CHARACTERISTICS OF THE BREAK SURFACE COULD NOT BE CLEARLY OBSERVED. THE SECOND PHOTO WAS THE PRODUCT LABEL FOR A POWERPICC PROVENA CATHETER WITH SOLO VALVE TECHNOLOGY WITH REF: CK000723 AND LOT: REBN1525. THE CHARACTERISTICS OF THE CRACKS IN THE PHOTO ARE CONSISTENT WITH A KNOWN ISSUE, THEREFORE, THE COMPLAINT IS CONFIRMED AS MANUFACTURING RELATED. REYNOSA EVALUATION: THE COMPLAINT FOR ¿CATHETER HUB CRACK¿ IS CONFIRMED ACCORDING TO THE PHOTO EVALUATION WHICH SHOWED A BREAK IN THE MOLDING GRAY VALVE, MAYBE THOSE ARE CAUSED BY THE INCORRECT MOLDING PROCESS, LEADING TO VALVE BREAKAGE. THIS CONDITION CAUSE LEAK IN THE DEVICE. THEREFORE THE CAUSE FOR THIS COMPLAINT IS MANUFACTURING RELATED. A LOT HISTORY REVIEW (LHR) OF REBN1525 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GREY HUB CRACKED ON THE CATHETER. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GREY HUB CRACKED ON THE CATHETER. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GREY HUB CRACKED ON THE CATHETER. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432253 POWERPICC SOLO CATHETER, 5F TL, TT, 3CG CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS REBN1525 00801741137679

    Patients

    Seq Age Sex Outcome Treatment
    1