BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    -INTIMA-II Y 24GAX0.75IN PRN/EC SLM

    MDR report key: 18282506 · Received December 7, 2023

    Report

    Report Number
    3006948883-2023-00125
    Event Type
    Malfunction
    Date Received
    December 7, 2023
    Date of Event
    November 11, 2023
    Report Date
    January 10, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903830336
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    1. CUSTOMER RETURNED 3 PHOTOS, NO ACTUAL SAMPLES. THE PHOTOS SHOW THAT THE CATHETER IS BROKEN, THE LENGTH OF THE RESIDUAL CATHETER IS ABOUT 1MM (THE DISTANCE BETWEEN THE BREAK OF THE CATHETER AND THE CATHETER HUB), THE BREAK SURFACE OF THE CATHETER IS INCLINED AND FLAT, THE CATHETER HAS NO WHITENED OR DEFORMED SIGNS, THE PINCH CLAMP IS IN THE CLAMPING STATE, AND THERE IS NO BLOOD RETURN IN THE EXTENSION TUBING. 2. DHR/BHR REVIEW(LOT#3080067): 1)THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN (B)(6) 2023, AND PACKAGED AT R240 PACKAGE LINE IN (B)(6) 2023. WORK ORDER QUANTITY WAS (B)(4) EA. 2)REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. 3)REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 4)REVIEW INCOMING INSPECTION RECORDS OF CATHETER, NO ABNORMALITIES. (MATERIAL NUMBER: B5171AAAL, BATCH NUMBER:2304672, 2304674, 3025613). 3. THE RETAINED SAMPLES OF THIS BATCH ARE TAKEN FOR LEAKAGE TEST AND CATHETER PULL FORCE TEST. NO LEAKAGE IS FOUND AT THE CATHETER, AND THE CATHETER PULL FORCES ARE WITHIN THE PRODUCT SPECIFICATIONS. PLEASE SEE ATTACHMENT PR#9257423-1 FOR THE TEST REPORTS. 4. CAUSE ANALYSIS: 1)THE LENGTH OF THE RESIDUAL CATHETER IS ABOUT 1MM, INDICATING THAT THE CATHETER IS BROKEN NEAR THE PUNCTURE SITE. IF THE CATHETER IS DAMAGED OR BROKEN EARLIER, OBVIOUS LEAKAGE WILL OCCUR. 2)THE PINCH CLAMP IS IN THE CLAMPING STATE AND THERE IS NO BLOOD RETURN IN THE EXTENSION TUBING, INDICATING THAT THE CATHETER BREAK IS OCCURRED IN THE NON-INFUSION INDWELLING STATE, THAT IS, THE PROCESSES OF EXHAUST, PUNCTURE, AND INFUSION BEFORE THE CATHETER BREAK ARE NORMAL. 3)THE CATHETER SHOWS NO SIGNS OF WHITENING OR DEFORMATION, INDICATING THAT THE CATHETER IS NOT STRETCHED TO BREAK OR IS STRETCHED TO BREAK AFTER BEING DAMAGED. WE HAVE CARRIED OUT A SIMULATION EXPERIMENT OF CATHETERS BEING CLAMPED OR PUNCTURED AND THEN STRETCHED TO BREAK. THE CATHETER WILL BE DEFORMED, WHITENED IN COLOR AND THIN IN THICKNESS DUE TO PLASTICITY. PLEASE SEE ATTACHMENT PR#9257423-2 FOR THE PHOTOS. 4)THE BREAK SURFACE OF THE CATHETER IS INCLINED AND FLAT, IT IS SUSPECTED THAT THE BREAK OF THE CATHETER IS CAUSED BY SHARP OBJECTS. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLES. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. THROUGH THE ANALYSIS OF THE STATUS OF THE RESIDUAL CATHETER SHOWN IN THE RETURNED PHOTOS, THE CATHETER BREAK IS SUSPECTED TO BE CAUSED BY SHARP OBJECTS, SUCH AS KNIVES, AND THE SPECIFIC PROCESS CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    DEVICE PROBLEM CODE: A0401 ¿ BREAK PATIENT PROBLEM CODE: F26 ¿ NO HEALTH CONSEQUENCES OR IMPACT (B)(4). INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    ON (B)(6) 2023 PATIENT WAS ADMITTED TO THE NEPHROLOGY DEPARTMENT WITH A FEVER RESULTING IN AN INFECTION OF THE URINARY TRACT SYSTEM, SUCCESSFUL PUNCTURE OF AN IV INDWELLING NEEDLE ON THE SAME DAY, THE PATIENT INFORMED THE NURSE AT 7:00 P.M. ON NOVEMBER 11 THAT HIS INTRAVENOUS INDWELLING NEEDLE HAD BROKEN OFF, THE DRESSING HAD FALLEN OFF, AND THE CATHETER WAS UNACCOUNTED FOR. WE WERE INFORMED ON NOVEMBER 15, AND NO INJURIES HAVE YET BEEN INCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222160 -INTIMA-II Y 24GAX0.75IN PRN/EC SLM CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON 3080067 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown