BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE ORAL 10ML AMBER

    MDR report key: 19716469 · Received July 10, 2024

    Report

    Report Number
    1213809-2024-00442
    Event Type
    Malfunction
    Date Received
    July 10, 2024
    Date of Event
    June 10, 2024
    Report Date
    January 6, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    KYW
    UDI-DI
    50382903052092
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP REPORT FOR CORRECTION AND DEVICE EVALUATION. THE EVENT/PRODUCT PROBLEM WAS INCORRECT IN THE INITIAL MDR. CORRECT EVENT/PRODUCT PROBLEM IS SILICONE VISIBLE. FOUR HUNDRED SAMPLES OF 10ML AMBER ORAL SYRINGES (P/N - 305209) BATCH 4018987 WERE RECEIVED AND EVALUATED. THE SAMPLES WERE RECEIVED IN FOUR BAGS EACH CONTAINING ONE HUNDRED SYRINGES. THREE BAGS WERE SEALED, AND ONE WAS UNSEALED. SILICONE WAS VISIBLE ON THE TIP OF MANY STOPPERS, HOWEVER, THE SILICONE OBSERVED IS NOT EXCESSIVE. FTIR ANALYSIS WAS PERFORMED AND CONFIRMED THE MOISTURE OBSERVED IN THE SYRINGES IS SILICONE USED IN THE MANUFACTURING PROCESS. THE CONDITION OBSERVED IS ACCEPTABLE PER PRODUCT SPECIFICATION. SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 20 YEARS, WITH ESTIMATED DISTRIBUTION WELL IN EXCESS OF 25 BILLION UNITS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED. SINCE THE REPORTED DEFECT IS CUSTOMER AWARENESS AND NOT A TRUE DEFECT, NO CORRECTIVE ACTIONS ARE NECESSARY. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 4018987 SHOWING NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECTS. 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

    POST INVESTIGATION FINDINGS REVEALED THAT THE FOREIGN MATTER WAS ACTUALLY SILICONE VISIBLE.

    Description of Event or Problem · 0

    MATERIAL# 305209 BATCH# 4018987 IT WAS REPORTED THAT THE BD SYRINGE ORAL 10ML AMBER HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT BD ORAL DISPENSING SYRINGE 10ML AMBER WITH TIP CAP. REF 305209. LOT: 009816. LOT: 4018987. PRODUCT HAS MOISTURE INSIDE SYRINGE. ADDITIONAL INFORMATION PROVIDED: 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY? 06-10-24- PRODUCT WAS FOUND TO HAVE MOISTURE INSIDE. CHECKED ALL BAGS AND IS PRESENT IN ALL BAGS. 2. PROVIDED LOT NUMBER [009816] WAS NOT FOUND IN OUR RECORDS. KINDLY PROVIDE THE VALID LOT NUMBER ASSOCIATED WITH REPORTED ISSUE. LOT# 4018987. 3. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO ISSUES- SAW MOISTURE AND DID NOT USE. 4. ANY SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? YES I HAVE THE ENTIRE CASE. PLEASE SEND TO (B)(6). 5. PLEASE SHARE THE CAPTURED PHOTO OF THE EVENT IF AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232950 BD SYRINGE ORAL 10ML AMBER CONTAINER, LIQUID MEDICATION, GRADUATED KYW BECTON DICKINSON MEDICAL SYSTEMS INCORRECT ENTRY 50382903052092

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown