BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL BNS

    MDR report key: 20655100 · Received November 11, 2024

    Report

    Report Number
    1213809-2024-00806
    Event Type
    Malfunction
    Date Received
    November 11, 2024
    Date of Event
    October 15, 2024
    Report Date
    January 9, 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

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4. OTHER LOT NUMBER INCLUDES 4243178 AND OTHER EXPIRATION DATE INCLUDES 2029-07-31. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. OTHER LOT NUMBER DEVICE MANUFACTURE DATE IS 2024-08-30.

    Additional Manufacturer Narrative · 0

    (B)(4) - SUPPLEMENTAL MDR - SCALE MARKING ISSUE. 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.

    Description of Event or Problem · 0

    MATERIAL#: 301029. BATCH#: 4243178, 4180037. IT WAS REPORTED THAT THE BD SYRINGE 10ML LL BNS HAD A SCALE MARKING ISSUE. 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 INFORMATION PROVIDED: 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. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2213451 BD SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4180037 50382903010290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown