BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WOVEN FILIFORM SPIRAL TIP

    MDR report key: 17134335 · Received June 15, 2023

    Report

    Report Number
    1018233-2023-04350
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Date of Event
    May 24, 2023
    Report Date
    October 23, 2023
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FBW
    UDI-DI
    00801741073175
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER ADDITIONAL INFORMATION RECEIVED, BD HAS DETERMINED THAT THIS MDR EVENT IS NOT REPORTABLE. SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CUSTOMER HAD BARD FOLLOWERS AND FILIFORMS BUT THE TIPS WERE NOT CONNECTING. (PCN 021114, PCN 021112, PCN 021116, PCN 021118, PCN 021120, PCN 021122, PCN 021124, PCN 021316, PCN 021100, PCN 021905, PCN 021906, PCN 022105). PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 06JUL2023, IT WAS REPORTED THAT CUSTOMER THOUGHT THERE MIGHT HAVE BEEN SOME CONFUSION WITH THIS. THERE WAS NOT ISSUE WITH THE PRODUCT ITSELF AND THEY HAD MISMATCHED FOLLOWERS AND FILIFORM ON HAND WHICH CAUSED AN ISSUE, ON THEIR END THEY FIGURED OUT THE ISSUE AND JUST HAD THE WRONG PRODUCTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CUSTOMER HAD BARD FOLLOWERS AND FILIFORMS BUT THE TIPS WERE NOT CONNECTING. (PCN 021114, PCN 021112, PCN 021116, PCN 021118, PCN 021120, PCN 021122, PCN 021124, PCN 021316, PCN 021100, PCN 021905, PCN 021906, PCN 022105)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230837 WOVEN FILIFORM SPIRAL TIP WOVEN FILIFORM SPIRAL TIP FBW C.R. BARD, INC. (COVINGTON) -1018233 022105 UNK 00801741073175

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other