BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTOR C35-O

    MDR report key: 20226453 · Received September 16, 2024

    Report

    Report Number
    3003152976-2024-00510
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    September 10, 2024
    Report Date
    January 3, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    ONB
    UDI-DI
    00382905150708
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION: MULTIPLE SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. ALL PRODUCTS WERE VISUALLY INSPECTED, NO DAMAGE OR OTHER DEFECTS WERE OBSERVED. FUNCTIONAL TESTING WAS PERFORMED, PASSING LIQUID THROUGH THE SYRINGE, INJECTOR, NEEDLE, AND CONNECTOR. IN ALL CASES THE PRODUCT FUNCTIONED AS INTENDED AND NO LEAKAGES BETWEEN ANY OF THE CONNECTIONS OCCURRED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE SUSPECTED LOTS 2301601, 2308501, AND 2309506, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING VERIFICATION ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION. RESULTS WERE REVIEWED FOR THE SUSPECTED LOTS AND NO ISSUES RELATED TO THE REPORTED EVENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION AND GIVEN THE DEVICE RECORDS DID NOT IDENTIFY ANY ISSUES RELATED TO THIS INCIDENT, A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS CANNOT BE IDENTIFIED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    MATERIAL # 515070 BATCH # UNKNOWN IT WAS REPORTED BY CUSTOMER THAT THE LEAK OCCURRED BETWEEN THE C35-0 CONNECTOR AND THE NEEDLE. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I HAVE HAD A OPPORTUNITY TO SPEAK TO THE NURSE AND THE LEAK DID NOT OCCUR WHERE I WAS INITIALLY TOLD. THE LEAK OCCURRED BETWEEN THE C35-0 CONNECTOR AND THE NEEDLE. PLEASE SEE THE ANSWERS TO YOUR QUESTIONS IN RED LOT NUMBER OF THE INJECTOR USED ( I REALIZE YOU MAY NOT HAVE THE INJECTOR THAT WAS USED, BUT CAN YOU GIVE ME A LOT FROM THE BIN IN WHICH YOU TOOK YOU SUPPLY FROM) INJECTOR (N35-0) LOT 2311304 OR 2308301 CONNECTOR (C35-0) LOT 2301601 OR LOT 2308501 OR LOT 2309506 WHAT BRAND SYRINGE WHERE YOU USING? IF THIS WAS A BD SYRINGE, WHAT IS THE SIZE (SKU) LOT NUMBER AND AGAIN PLEASE KEEP SOME SAMPLES? SYRING IS BD 3ML LOT 4142402 OR LOT 4129704 WAS IT A DROPLET, DROPLETS OR MLS THAT WHERE LEAKING? 2-3 DROPLETS DID THE PATIENT MISS SOME OF HIS/HER DOSE BECAUSE OF THIS? THE PATIENT DID NOT GET THEIR FULL DOSE. PATIENT GOT APPROX. 1/2 THEIR DOSE WHAT DRUG WAS THE NURSE EXPOSED TO? BORTEZOMIB DID THE NURSE CONTINUE TO GIVE THE INFUSION WITH THE LEAKING INJECTOR, OR DID SHE TAKE OFF AND ADD ANOTHER ONE? THE NURSE ATTACHED A C35-0 CONNECTOR TO THE N35-0 INJECTOR, AND THEN A NEEDLE ATTACHING TO C35-05 CONNECTOR. THE LEAK OCCURRED BETWEEN THE NEEDLE AND THE C35-0 CONNECTOR. NEEDLE = BD SAFETYGLIDE 25G X 5/8¿ TW (05MM X 16MM) LOT # 4116101. I WILL INCLUDE 3 SAMPLES TO SEND TO YOU THE TWO SKUS INVOLVED IN THIS PIR ARE THE C35-O CONNECTOR 515070 AND THE BD SAFETY GLIDE NEEDLE LISTED BELOW. ( THE INJECTOR HAS NOTHING TO DO WITH THIS PIR) YOU MAIN CONTACT IS (B)(6) SHE IS HOLDING SAMPLES OF THE SKUS FROM THE SAME LOT USED AND WILL RETURN ONCE YOU PROVIDE A FEDEX LABEL.

    Description of Event or Problem · 0

    MATERIAL # 515070, BATCH # UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THE LEAK OCCURRED BETWEEN THE C35-0 CONNECTOR AND THE NEEDLE. RCC RECEIVED A COMPLAINT VIA EMAIL. I HAVE HAD AN OPPORTUNITY TO SPEAK TO THE NURSE AND THE LEAK DID NOT OCCUR WHERE I WAS INITIALLY TOLD. THE LEAK OCCURRED BETWEEN THE C35-0 CONNECTOR AND THE NEEDLE. PLEASE SEE THE ANSWERS TO YOUR QUESTIONS IN RED. LOT NUMBER OF THE INJECTOR USED (I REALIZE YOU MAY NOT HAVE THE INJECTOR THAT WAS USED, BUT CAN YOU GIVE ME A LOT FROM THE BIN IN WHICH YOU TOOK YOU SUPPLY FROM) INJECTOR (N35-0) LOT 2311304 OR 2308301 CONNECTOR (C35-0) LOT 2301601 OR LOT 2308501 OR LOT 2309506 WHAT BRAND SYRINGE WHERE YOU USING? IF THIS WAS A BD SYRINGE, WHAT IS THE SIZE (SKU) LOT NUMBER AND AGAIN PLEASE KEEP SOME SAMPLES? SYRING IS BD 3ML LOT 4142402 OR LOT 4129704 WAS IT A DROPLET, DROPLETS OR MLS THAT WHERE LEAKING? 2-3 DROPLETS DID THE PATIENT MISS SOME OF HIS/HER DOSE BECAUSE OF THIS? THE PATIENT DID NOT GET THEIR FULL DOSE. PATIENT GOT APPROX. 1/2 THEIR DOSE WHAT DRUG WAS THE NURSE EXPOSED TO? BORTEZOMIB DID THE NURSE CONTINUE TO GIVE THE INFUSION WITH THE LEAKING INJECTOR, OR DID SHE TAKE OFF AND ADD ANOTHER ONE? THE NURSE ATTACHED A C35-0 CONNECTOR TO THE N35-0 INJECTOR, AND THEN A NEEDLE ATTACHING TO C35-05 CONNECTOR. THE LEAK OCCURRED BETWEEN THE NEEDLE AND THE C35-0 CONNECTOR. NEEDLE = BD SAFETYGLIDE 25G X 5/8¿ TW (05MM X 16MM) LOT # 4116101. I WILL INCLUDE 3 SAMPLES TO SEND TO YOU. THE TWO SKUS INVOLVED IN THIS PIR ARE THE C35-O CONNECTOR 515070 AND THE BD SAFETY GLIDE NEEDLE LISTED BELOW. (THE INJECTOR HAS NOTHING TO DO WITH THIS PIR). YOU MAIN CONTACT IS (B)(6). SHE IS HOLDING SAMPLES OF THE SKUS FROM THE SAME LOT USED AND WILL RETURN ONCE YOU PROVIDE A FEDEX LABEL. 1. COULD YOU PLEASE CONFIRM IF YOU HAVE ENGAGED THE CONNECTOR WITH THE INJECTOR BEFORE THE ATTACHED THE NEEDLE? CONNECTOR ATTACHED TO INJECTOR, THEN NEEDLE ATTACHED TO CONNECTOR. 2. WHEN THE LEAKAGE OCCURRED? BEFORE ADMINISTRATION OR ONCE THE INJECTION BEGAN? LEAK OCCURRED DURING INJECTION OF MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308780 CONNECTOR C35-O CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB BECTON DICKINSON UNKNOWN 00382905150708

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown