BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD CATHETER NEEDLE

    MDR report key: 17996606 · Received October 24, 2023

    Report

    Report Number
    2243072-2023-01919
    Event Type
    Malfunction
    Date Received
    October 24, 2023
    Date of Event
    August 27, 2023
    Report Date
    December 8, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903830787
    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. DHR/BHR REVIEW(LOT#3080066): 1)THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN (B)(6) 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. 2. NO ACTUAL SAMPLES AND PICTURES HAVE BEEN RECEIVED, AND THE SPECIFIC LOCATION, STATUS AND COMPOSITION OF THE WHITE FOREIGN MATTER CANNOT BE IDENTIFIED. 3. CHECK THE RETAINED SAMPLES OF THIS BATCH, NO FOREIGN MATTER IS FOUND, PLEASE SEE THE ATTACHED PHOTOS. 4. 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. AS NO DEFECTIVE SAMPLE RETURNED, THE ROOT CAUSE OF THE WHITE FOREIGN MATTER ON THE INDWELLING NEEDLE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(6) HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMAITON PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING UNSPECIFIED BD CATHETER NEEDLE THERE WAS FOREIGN MATTER. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: (B)(6) 2023 WHILE ADMINISTERING FLUIDS, A NURSE ADMINISTERED AN INDWELLING NEEDLE TO A PATIENT, TORE OPEN THE PACKAGE AND FOUND A WHITE FOREIGN SUBSTANCE ON THE NEEDLE AND DISCARDED THE NEEDLE, WHICH WAS DISCOVERED IN A TIMELY MANNER AND DID NOT RESULT IN AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1276237 UNSPECIFIED BD CATHETER NEEDLE INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 3080066 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown