BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC PROVENA SOLO 5F TL MAX BARRIER PLUS KIT W/GUARDIVA

    MDR report key: 13601652 · Received February 25, 2022

    Report

    Report Number
    3006260740-2022-00494
    Event Type
    Malfunction
    Date Received
    February 25, 2022
    Date of Event
    February 7, 2022
    Report Date
    June 16, 2022
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    K072230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATE OF EVENT WAS NOT PROVIDED BY THE COMPLAINANT/REPORTER, THE DATE REFLECTED IN THIS REPORT IS THE DATE BD BECAME AWARE OF THE EVENT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REFX0106 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER HAVE BEEN REPORTED FROM THE SAME FACILITY.

    Additional Manufacturer Narrative · 0

    THE DATE OF EVENT WAS NOT PROVIDED BY THE COMPLAINANT/REPORTER, THE DATE REFLECTED IN THIS REPORT IS THE DATE BD BECAME AWARE OF THE EVENT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REFX0106 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER HAVE BEEN REPORTED FROM THE SAME FACILITY.

    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 FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, COMPLAINT AND LOT HISTORY REVIEW, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), APPLICABLE MANUFACTURE RECORDS, AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF KINKED STYLETS IS CONFIRMED; HOWEVER, THE EXACT CAUSE IS UNKNOWN. THREE 3CG STYLETS AND ONE 5 FR TRIPLE LUMEN POWERPICC PROVENA SOLO WERE RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION SHOWED SOME USE RESIDUE ON TWO OF THE RETURNED SAMPLES, NO OBVIOUS EVIDENCE OF USE WAS OBSERVED ON THE OTHER SAMPLE, WHICH WAS RETURNED WITHIN A T-LOCK IN THE RED LUMEN OF THE CATHETER WITH APPROXIMATELY 20 CM OF THE STYLET PROTRUDING FROM THE T-LOCK. BENDS WERE OBSERVED IN THE RETURNED STYLETS APPROXIMATELY 1.5 CM PROXIMAL TO THE DISTAL TIP OF ONE SAMPLE, 5 CM PROXIMAL TO THE DISTAL TIP OF ANOTHER SAMPLE, AND 5.7 TO THE DISTAL TIP OF THE SAMPLE RETURNED WITHIN THE CATHETER. NO BREAKS WERE OBSERVED IN THE CORE WIRE OF THE STYLETS AND THE DISTAL TIPS WERE FOUND TO BE PRESENT AND INTACT. A MICROSCOPIC OBSERVATION REVEALED NO BREAKS OR TEARS IN THE TUBING AT THE DISTAL END OF THE RETURNED STYLETS, AND THE BENDS WITHIN THIS TUBING OF EACH STYLET WERE FOUND TO BE AT THE INTERFACING OF TWO MAGNETS IN TWO OF THE SAMPLES, AND AT THE PROXIMAL END OF THE MAGNETS IN THE SAMPLE RETURNED WITHIN A CATHETER. INSUFFICIENT EVIDENCE WAS FOUND ON THE RETURNED SAMPLES TO INDICATE A SPECIFIC ROOT CAUSE OF THE BENDS IN THE STYLETS; HOWEVER, POSSIBLE CONTRIBUTING FACTORS INCLUDE ADVANCEMENT OF THE STYLETS AGAINST RESISTANCE AND DAMAGE DURING MANIPULATION, HANDLING, OR USE. H3 OTHER TEXT : EVALUATION FINDINGS ARE IN SECTION H.11

    Description of Event or Problem · 0

    IT WAS REPORTED "CUSTOMER HAS 2 WIRES FROM PICC KITS ONE WAS KINKED BEFORE INSERTION AND ONE WAS KINKED AFTER INSERTION." THIS REPORT ADDRESSES THE KINK AFTER INSERTION.

    Description of Event or Problem · 0

    IT WAS REPORTED "CUSTOMER HAS 2 WIRES FROM PICC KITS ONE WAS KINKED BEFORE INSERTION AND ONE WAS KINKED AFTER INSERTION." THIS REPORT ADDRESSES THE KINK AFTER INSERTION.

    Description of Event or Problem · 0

    IT WAS REPORTED "CUSTOMER HAS 2 WIRES FROM PICC KITS ONE WAS KINKED BEFORE INSERTION AND ONE WAS KINKED AFTER INSERTION." ON 06/06/2022-THREE DEVICES WERE RETURNED. THIS REPORT ADDRESS THE SECOND DEVICE (KINK AFTER INSERTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2359050 POWERPICC PROVENA SOLO 5F TL MAX BARRIER PLUS KIT W/GUARDIVA CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A REFX0106

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other