BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD POWERME

    MDR report key: 18335994 · Received December 15, 2023

    Report

    Report Number
    3014704491-2023-00814
    Event Type
    Injury
    Date Received
    December 15, 2023
    Date of Event
    November 20, 2023
    Report Date
    January 24, 2024
    Manufacturer
    BD (SUZHOU)
    Product Code
    PND
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    1. PRODUCTION LOT RECORD CHECK (LOT#3068424) : 1) THE PRODUCT SPECIFICATION IS 20GX10CM, SKU NUMBER IS 980021, THE PRODUCTION DATE IS 2023/04, AND LOT QUANTITY IS (B)(4). 2) CHECK THE PROCESS TEST REPORT AND OUTGOING TEST REPORT, THE TEST RESULTS MEET THE PRODUCT STANDARDS, NO ABNORMALITIES. 3) CHECK PRODUCTION RECORDS FOR NO NONCONFORMITIES, DEVIATIONS OR REWORK ACTIVITIES. 2. THE RETURNED SAMPLE HAS BEEN RECEIVED, THE PRODUCT HAS BEEN USED. THERE IS A V-SHAPED PUNCTURE NOTCH ON SECTION OF CATHETER, THE SECTION OF THE BROKEN CATHETER IS NOT WHITE AND DEFORMATION. THE GUIDEWIRE IS BROKEN IN CATHETER, AND THE CATHETER IS PUNCTURED AT THE END OF THE BROKEN GUIDEWIRE. REFER TO ATTACHED PHOTO 1,2,3. 3.A SIMULATION TEST WAS CARRIED OUT WHICH WAS PULLED BY EXTERNAL FORCE DIRECTLY, AND THE SECTION OF THE FRACTURE WAS WHITE WITH OBVIOUS DEFORMATION, AS SHOWN IN THE ATTACHED PICTURE 4 CUT THE CATHETER WITH A SHARP TOOL, AND THE SECTION IS SMOOTH, WITHOUT WHITENING AND PLASTIC DEFORMATION, AS SHOWN IN THE ATTACHED PICTURE 5 THE SIMULATED CANNULA PUNCTURES THE CATHETER AND PULLS IT OFF, WITH V-SHAPED PUNCTURES AND UNEVEN SECTIONS, AS SHOWN IN ATTACHED PICTURES 6 AND 7. 4. SUMMARY: ACCORDING TO THE NORMAL OPERATION PROCEDURE, THE GUIDE WIRE SHOULD BE ADVANCED AFTER SUCCESSFUL PUNCTURE, AND THE GUIDE WIRE SHOULD BE PUSHED TO THE END BEFORE THE CATHETER IS SENT. WHEN THE CATHETER HEAD EXCEEDS THE GUIDE WIRE, IT MAY BE DIFFICULT TO ADVANCE. WHEN THE CATHETER IS PULLED BACK, IF THE PUNCTURE ANGLE IS LARGE, THE NEEDLE WILL PUNCTURE THE CATHETER, AND THE FRACTURE SECTION SIMILAR TO THE SAMPLE RETURNED BY THE CUSTOMER WILL APPEAR AFTER BEING PULLED APART BY EXTERNAL FORCE. THE CATHETER WAS PUNCTURED BY THE CANNULA DURING REPEATED CATHETER ADVANCE, CAUSED THE GUIDE WIRE BEING PINNED BY THE CANNULA AND THE CATHETER AT THE PUNCTURED POSITION, AND BEING PULLED OFF BY EXTERNAL FORCES WHEN THE GUIDEWIRE WAS WITHDRAWN. 5. COUNTERMEASURE: PLANT HAVE SUMMARIZED THE REPORT FOR CATHETER FRACTURE AND INFORM MARKETING COLLEAGUES TO TRAIN CUSTOMERS. IT IS RECOMMENDED THAT THE CUSTOMER FOLLOW THE IFU INSTRUCTIONS. AFTER THE CATHETER IS ADVANCED, DO NOT DIRECTLY WITHDRAW THE CATHETER OR GUIDEWIRE WHILE THE NEEDLE REMAINS IN THE CATHETER. IF THE CATHETER NEEDS TO BE WITHDRAWN, KEEP THE NEEDLE AND CATHETER SIMULTANEOUSLY OR WITHDRAW THE CATHETER AFTER THE NEEDLE IS WITHDRAWN, AS SHOWN IN THE ATTACHED IFU SCREENSHOT PICTURE 8. H3 OTHER TEXT : SEE NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD POWERME CATHETER BROKE THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; PRODUCT TUBE PLACEMENT WAS BROKEN DURING TUBE PLACEMENT, UNBROKEN TUBE WAS IN THE PATIENT'S BODY; SAMPLES CAN BE RETURNED, WITH PHOTOS PROVIDED; COMPLAINT RESPONSE LETTER REQUIRED, NO LETTER OF ACCEPTANCE REQUIRED; NO GREEN CLAIMS REQUIRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928332 BD POWERME MIDLINE CATHETER PND BD (SUZHOU) 3068424

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention