BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD POWERMIDLINE CATHETER (4F) (SINGLE-LUMEN) (20CM)

    MDR report key: 14388252 · Received May 13, 2022

    Report

    Report Number
    3006260740-2022-01751
    Event Type
    Malfunction
    Date Received
    May 13, 2022
    Date of Event
    April 21, 2022
    Report Date
    June 9, 2022
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    PND
    UDI-DI
    00801741141126
    PMA / PMN Number
    K153393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REFZ2376 SHOWED TWO 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED "FOUND OUT THERE ARE A TOTAL OF 3 MIDLINES FROM THE SAME LOT LEAKING AT THE INSERTION SITE. WHEN THEY PULLED THE MIDLINE AND FLUSHED, EXAMINED THEY DID NOT NOTICE ANYTHING WRONG WITH THE CATHETER BUT THEY HAVE ALSO BEEN USING THESE FOR YEARS WITH NO ISSUES. WE WENT THROUGH SEVERAL TROUBLESHOOTING TECHNIQUES WHICH WE FEEL THIS COULD BE MED OR PATIENT ANATOMY ISSUES BUT STILL WANT TO REPORT. 2 EXCHANGED AND 1 WENT TO NPO MEDS" THIS REPORT ADDRESSES THE NPO MEDS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED "FOUND OUT THERE ARE A TOTAL OF 3 MIDLINES FROM THE SAME LOT LEAKING AT THE INSERTION SITE. WHEN THEY PULLED THE MIDLINE AND FLUSHED, EXAMINED THEY DID NOT NOTICE ANYTHING WRONG WITH THE CATHETER BUT THEY HAVE ALSO BEEN USING THESE FOR YEARS WITH NO ISSUES. WE WENT THROUGH SEVERAL TROUBLESHOOTING TECHNIQUES WHICH WE FEEL THIS COULD BE MED OR PATIENT ANATOMY ISSUES BUT STILL WANT TO REPORT. 2 EXCHANGED AND 1 WENT TO NPO MEDS" THIS REPORT ADDRESSES THE NPO MEDS DEVICE. ADDITIONAL INFO. RECEIVED 05/11/2022. "AT WHAT POINT DURING DEVICE USE WAS THE LEAK DISCOVERED (I.E. INSERTION, INFUSION, REMOVAL)WAS THE CATHETER FRACTURE INTERNAL TO THE PATIENT OR EXTERNAL?INFUSION 2. WHAT WAS INFUSION WHEN THE LEAK WAS DISCOVERED? MEROPENUM. 3. ANY PATIENT SYMPTOMS RELATED TO FLUID LEAK? NO. 4. WAS THE CATHETER REMOVED? WAS A NEW CATHETER PLACED? YES AND YES. 5. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? STATLOCK. 6. A DETAILED DESCRIPTION OF THE EVENT: 7. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? MIDLINE. 8. DATE OF OCCURRENCE: 4/21 FIRST LINE REPLACED WITH ANOTHER MIDLINE. 9. PLACEMENT DATE: 4/11. 10. EXPLANT DATE: UNSURE DO TO PATIENT BEING OUTPATIENT AND HOME CARE WAS MANAGING LINE. 1. WAS THERE ANY PATIENT HARM REPORTED? NO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667758 BARD POWERMIDLINE CATHETER (4F) (SINGLE-LUMEN) (20CM) MIDLINE CATHETER PND C.R. BARD, INC. (BASD) -3006260740 N/A REFZ2376 00801741141126

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other