BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML X 31G X 6MM U-500 B/P

    MDR report key: 22579339 · Received July 23, 2025

    Report

    Report Number
    3024508819-2025-00270
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    June 2, 2025
    Report Date
    August 5, 2025
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    UDI-DI
    00382903267309
    PMA / PMN Number
    K151870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H11. INVESTIGATION SUMMARY: ADDITIONAL INFORMATION RECEIVED, SITUATION ANALYSIS EMBC-25-0007-SA AND CAPA PR-00056 WERE OPENED TO ADDRESS THIS COMPLAINT.

    Additional Manufacturer Narrative · 0

    THIS MEDWATCH SUBMISSION IS BOTH AN INITIAL AND SUPPLEMENTAL FILING. INVESTIGATION OF THE RESULTS CAN BE SEEN BELOW: INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED.

    Description of Event or Problem · 0

    VA REPORTED VIA EMAIL - FOUND TWO U-100 SYRINGES WITH A GREEN NEEDLE SHIELD IN A U-500 PACKET. LOT # 3058741. LOT # 1291172. CATALOG# 326730. DATE OF EVENT 06/02/2025. ASKING IS MAIL KIT SHOULD BE SENT TO THIS VA PHARMACIST. PLEASE LOOK INTO THIS REQUEST. REGARDS, CUSTOMER SUPPORT ON TUE, JUN 3 6:56 AM , NAME REMOVED (B)(6) WROTE: GOOD AFTERNOON, I AM LOOKING TO CONNECT WITH SOMEONE AT BD/EMBECTA TO REVIEW A PRODUCT ISSUE WITH U-500 SYRINGES. WE WOULD LIKE TO CLARIFY IF THIS IS THE INTENDED DESIGN BY BD OR A SAFETY ISSUE WITH THE LOT. THE U-500 SYRINGES TYPICALLY HAVE A GREEN CAP WITH MARKINGS OF 25-250 AT 0.5ML. WE WOULD LIKE TO KNOW IF BD/EMBECTA HAS A GREEN TIP U-500 SYRINGE WITH THESE DIFFERENT MARKINGS OF 5-50 ¿ AND IF WE SHOULD ASSIST WITH A SAFETY REPORT FOR REVIEW/VALIDATION. RESPECTFULLY, (B)(6). FROM: (B)(4) CUSTOMER SUPPORT EMAIL TO CASE <[email protected]> SENT: MONDAY, JUNE 2, 2025 2:50 PM TO (B)(6). SUBJECT: [EXTERNAL] RE: U-500 PRODUCT SAFETY QUESTION. HELLO, BD IS UNABLE TO COMPLETE YOUR REQUEST AS THE PREVIOUS DIABETES CARE DIVISION OF BD WAS SEPARATED IN 2022 INTO A SEPARATE PUBLIC COMPANY CALLED EMBECTA CORP. AS PART OF THE SEPARATION, BD LICENSED THE USE OF THE NAME ¿BD¿ TO EMBECTA FOR A TRANSITIONAL PERIOD UNTIL EMBECTA IS ABLE TO CHANGE THE BRANDING ON THE DIABETES CARE BOXES FROM BD TO EMBECTA. HOWEVER, GIVEN THESE PRODUCTS ARE MANUFACTURED AND SOLD BY EMBECTA, EMBECTA, NOT BD, MANAGES ANY QUESTIONS AROUND INSULIN RELATED PRODUCTS. YOU MAY REACH EMBECTA AT 888-232-2737 OR [email protected]< THANK YOU FOR REACHING OUT TO BD (B)(4). CUSTOMER CARE. ORIGINAL MESSAGE FROM: NAME REMOVE (B)(6). SENT: 6/2/2025 1:30 PM. TO: SUBJECT: U-500 PRODUCT SAFETY QUESTION. GOOD AFTERNOON, I AM LOOKING TO CONNECT WITH SOMEONE AT BD TO REVIEW A PRODUCT ISSUE WITH U-500 SYRINGES. WE WOULD LIKE TO CLARIFY IF THIS IS THE INTENDED DESIGN BY BD OR A SAFETY ISSUE WITH THE LOT. THE U-500 SYRINGES TYPICALLY HAVE A GREEN CAP WITH MARKINGS OF 25-250 AT 0.5ML. WE IDENTIFIED A U-100 LABELED SYRINGE WITH A GREEN CAP WITH MARKINGS OF 5-50. THE LOT WAS EITHER 3058741 OR 1291172. WE WOULD LIKE TO KNOW IF BD HAS A GREEN TIP U-500 SYRINGE WITH THESE DIFFERENT MARKINGS OF 5-50 ¿ AND IF WE SHOULD ASSIST WITH A SAFETY REPORT FOR REVIEW/VALIDATION. RESPECTFULLY, XXXX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855041 SYRINGE 0.5ML X 31G X 6MM U-500 B/P SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 000000000000326730 3255432 00382903267309

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown