BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL BNS

    MDR report key: 20772490 · Received November 25, 2024

    Report

    Report Number
    1213809-2024-00881
    Event Type
    Malfunction
    Date Received
    November 25, 2024
    Date of Event
    October 10, 2024
    Report Date
    January 25, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903010290
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    MATERIAL#: 301029. BATCH#: 4222670, 4243176. IT WAS REPORTED THAT THE BD SYRINGE 10ML LL BNS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. PRODUCT COMPLAINTS/ CLAIMS NOT SURE WHO SHOULD HANDLE THIS ONE. HCT IS A DISTRIBUTOR AND NOTICED SOME UNCONFORMITIES ON THE SKU¿S BELOW. THEY WOULD LIKE TO RETURN. CUSTOMER CC¿D. 302995 ¿ 10ML 309646 ¿ 5ML REJECTED NON-STERILE SYRINGES. SYRINGES DID NOT PASS INSPECTION. CAN YOU PLEASE ADVISE HOW YOU WOULD LIKE US TO HANDLE THE REJECTED SYRINGES? SHOULD WE JUST EMAIL YOU WHAT CANNOT BE USED FOR A CREDIT? DO YOU NEED THEM RETURNED OR CAN WE DISPOSE OF THEM? HI (B)(6). WE HAVE IDENTIFIED A NONCONFORMITY IN 5 AND 10ML BD SYRINGES (LOTS: 4183027 4227266 4243178 4180037). WE ARE INSPECTING APPROXIMATELY (B)(4) SYRINGES FOR CONTAMINATION AND (B)(4) SYRINGES FOR PRINTING. THANK YOU XXXXX. ADDITIONAL INFO: 1. DID THE ISSUE HAPPEN DURING PATIENT USE? IF YES, WAS THERE ANY INJURY? IF SO, PLEASE DESCRIBE AND INCLUDE ANY MEDICAL TREATMENT NEEDED AS A RESULT? NO. 2. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO. 3. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? CHECKING 4. BATCH NUMBER [4243178, 4180037] WAS NOT FOUND FOR MATERIAL NUMBER # 302995, KINDLY VERIFY THE SAME. CHECKING. 5. TOTAL NUMBER OF OCCURRENCES OF ONLY 10 ML SYRINGE? CHECKING. 6. ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? 7. INSPECTED (B)(4) SYRINGE FOR PRINTING, CAN YOU PLEASE ELABORATE THIS ISSUE WHY THIS WAS INSPECTED? WHETHER ANY SCALE MARKING ISSUE ON THE SYRINGE. MY UNDERSTANDING IS THIS WAS AN ISSUE WITH THE 5ML BUT I AM CONFIRMING. ADDITIONAL INFO: GOOD MORNING, REGARDING THE 10 ML SYRINGES: INSPECTION WAS DONE ON 10/10 AND 10/14. LOTS AFFECTED ARE 4180037, 4222670, 4243176, AND 4243178. (B)(4) EACH HAD CONTAMINANTS AND (B)(4) HAD LABELING ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630472 BD SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4222670 50382903010290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown