BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31G 6MM HALF UNIT 10BAG CA

    MDR report key: 19276105 · Received May 9, 2024

    Report

    Report Number
    3024508819-2024-00045
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Report Date
    August 1, 2024
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION INCLUDED IN B4, H2, H11 CORRECTED SECTION E1 (COUNTRY TYPE), H6 (TYPE OF INVESTIGATION AND INVESTIGATION CONCLUSION) INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    APPROXIMATELY 100 SYRINGE UNITS IMPACTED. SEE ENCLOSED MEDWATCH FORM SECTION C.

    Description of Event or Problem · 0

    LOT: 3052676 CATALOG: 324919 HAD TO REACH OUT TO CONSUMER A SECOND TIME TO CONFIRM PRODUCT INFORMATION. WHEN I TRIED TO ENTER PRODUCT INFORMATION UNDER "RELATED" AND "CASE PRODUCT DETAILS", THE SYSTEM DID NOT RECOGNIZE IT. CONSUMER INSIST THESE ARE THE NUMBERS ON THE BOX. FROM: PRODUCTCOMPLAINTS <[email protected]> SENT: MONDAY, APRIL 15, 2024 11:38 AM TO: PRODUCTCOMPLAINTS <[email protected] SENT: SUNDAY, APRIL 14, 2024 9:34 PM TO: PRODUCTCOMPLAINTS <[email protected]<MAILTO:[email protected]>> SUBJECT: BD SYRINGE ISSUE HELLO, I HAVE NOW HAD TWO BOXES OF BD ULTRA FINE SYRINGES (6MM, 31G, 30 UNIT CAPACITY) PICKED UP FROM A CANADIAN PHARMACY WITH A PROBLEM WITH ABOUT HALF TO TWO-THIRDS OF THE SYRINGES. THE PROBLEM IS: WITH A FRESH NEW SYRINGE, I PUSH THE PLUNGER UP TO PUSH OUT THE 1 UNIT OF AIR, AND IT ALSO PUSHES OUT A DROP OR TWO OF LIQUID. BECAUSE OF THIS LIQUID, I'VE HAD TO DISCARD 1/3 TO 1/2 OF THE SYRINGES IN TWO BOXES NOW. WHAT IS THE LIQUID? WHAT'S CAUSING THIS? THE LOT NUMBER OF THE CURRENT BOX IS 3052676. DATE OF MANUFACTURE: 2023-04-02. PLEASE DO GET BACK TO ME WITH MORE INFORMATION ABOUT WHAT'S GOING ON HERE. I LOOK FORWARD TO HEARING FROM YOU. BEST,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489215 SYRINGE 0.3ML 31G 6MM HALF UNIT 10BAG CA SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 324919 3052676

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown