BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM

    MDR report key: 20669717 · Received November 12, 2024

    Report

    Report Number
    3002601200-2024-00606
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Date of Event
    October 19, 2024
    Report Date
    November 25, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830190
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    1. DHR/BHR REVIEW LOT#4052033. 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN MARCH 2024, AND PACKAGED AT CFS PACKAGE LINE IN MARCH 2024. WORK ORDER QUANTITY WAS 198,000 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. 2. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. 45PSI LEAKAGE TEST IS CARRIED OUT ON THE RETAINED SAMPLE OF THIS BATCH, AND NO LEAKAGE IS FOUND. PLEASE REFER TO ATTACHMENT FOR THE TEST REPORT. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITIES ARE FOUND IN THE PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. BECAUSE THE DEFECT STATES AT THE CONNECTION BETWEEN THE CONNECTOR AND THE NEEDLE OF THE COMPLAINED SAMPLE CANNOT BE IDENTIFIED, THE ROOT CAUSE OF THE LEAKAGE THERE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 22 GA X 1.00 INCH PRN/EC SLM LEAKED AT ADAPTER TUBING JUNCTION. "ON (B)(6) 2024, DURING AN INFUSION IN A PATIENT ON BED 8, AN INDWELLING NEEDLE CONNECTOR LEAKED AT THE CONNECTION TO THE SCALP NEEDLE, RESULTING IN A SOAKED SHEET, LEAKAGE OF MEDICATION, AND THE NEED FOR A SECOND PUNCTURE, MAKING THE PATIENT MORE OPINIONATED, RESULTING IN PATIENT DISTRESS AND DECREASED SATISFACTION. IMMEDIATELY REPLACE THE NEW INDWELLING NEEDLE, DO A GOOD JOB OF EXPLAINING TO THE PATIENT, OBTAIN COOPERATION, AND RE-PUNCTURE."

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1540265 BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052033 00382903830190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown