BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18248248 · Received December 1, 2023

    Report

    Report Number
    3014704491-2023-00785
    Event Type
    Malfunction
    Date Received
    December 1, 2023
    Date of Event
    November 7, 2023
    Report Date
    May 15, 2025
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830695
    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. AS DESCRIBED IN THE ATTACHMENT: THE PRODUCT FAILURE IS MANIFESTED AS THE INTERFACE CANNOT BE TIGHTENED WHEN CONNECTING THE INFUSION SET AFTER INTRAVENOUS INJECTION. NO ACTUAL SAMPLES AND PHOTOS RETURNED. 2. DHR/BHR REVIEW(LOT#3080074): 1)THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN APRIL 2023, AND PACKAGED AT R240 PACKAGE LINE IN APRIL 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. 3. THE RETAINED SAMPLE OF THE COMPLAINED BATCH IS TAKEN FOR LEAKAGE TEST, AND NO LEAKAGE IS FOUND AT THE CONNECTION BETWEEN THE PP CONNECTOR AND THE PRN, THE END CAP. PLEASE SEE THE ATTACHED TEST REPORT. 4. ACCORDING TO THE PRODUCT DESIGN, THE PP CONNECTOR OF THE PRODUCT CAN BE CONNECTED WITH ISO LUER JOINT, IT IS RECOMMENDED TO USE ISO LUER JOINT TO CONNECT WITH THE PRODUCT. 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 SAMPLE. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. SINCE THE DEFECT STATUS OF THE COMPLAINED SAMPLE CANNOT BE IDENTIFIED, THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    BECTON DICKINSON AND COMPANY'S (BD) MEDICATION DELIVERY SOLUTIONS (MDS) BUSINESS UNIT WILL DISCONTINUE MALFUNCTION MDR REPORTING FOR CERTAIN DEVICE FAILURES THAT HAVE NOT CAUSED OR CONTRIBUTED TO DEATHS OR SERIOUS INJURIES IN THE PAST TWO YEARS, AND WHERE THE LIKELIHOOD OF A DEATH OR SERIOUS INJURY AS A RESULT OF THESE MALFUNCTIONS IS REMOTE. THIS DECISION FOLLOWS FDA GUIDELINES (MEDICAL DEVICE REPORTING FOR MANUFACTURERS GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF ISSUED NOV 8, 2016, REFERENCE SECTION 2.15). BD NOTIFIED FDA OF THIS DECISION ON MAR 3, 2025. FDA HAS REVIEWED AND RESPONDED TO BD¿S NOTIFICATION (REFERENCE FDA DOCUMENT # (B)(4)) ON MARCH 7, 2025. THIS DOCUMENTATION IS AVAILABLE IN BD DOCUMENT MANAGEMENT SYSTEM (SAP) AS (B)(4). THIS SUPPLEMENTAL MDR IS BEING FILED TO DOCUMENT THAT THE BELOW DEVICE FAILURE WILL NO LONGER BE CONSIDERED A REPORTABLE MALFUNCTION MDR FOR THE PRODUCT FAMILY BELOW: PRODUCT FAMILY: INTIMA II. DEVICE FAILURE: CONNECTION ISSUES.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC HAD A CONNECTOR LOOSE THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; THE PATIENT'S CONNECTOR CANNOT BE TIGHTENED WHEN CONNECTING FLUIDS AFTER INJECTION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399310 BD INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3080074 00382903830695

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown