BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II - 2-PIECE SYRINGE

    MDR report key: 16740436 · Received April 13, 2023

    Report

    Report Number
    2243072-2023-00616
    Event Type
    Malfunction
    Date Received
    April 13, 2023
    Date of Event
    March 20, 2023
    Report Date
    April 28, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A PHOTO WAS RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTO OF A DISCARDIT II 5ML WITH 23X1 FROM THE LOT 2277715 REGARDING MATERIAL NUMBER 300852 WITH THE REPORTED COMPLAINT OF LEAKAGE. NO CONCLUSION CAN BE DERIVED FROM THE RECEIVED PHOTOGRAPH. THE DEVICE HISTORY REVIEW OF MATERIAL NUMBER 300852 AND LOT NUMBER 2277715 WAS CHECKED AND THERE WAS NO QUALITY NOTIFICATION FOUND ON THIS LOT NUMBER FROM ITS PRODUCTION DATE TO ITS DISPATCH ON DATE. THE INVESTIGATION AND SIMULATION WERE CARRIED OUT ON 1 RETENTION SAMPLE WHERE THE INVESTIGATING TEAM HAS TESTED FOR LEAKAGE. NO LEAKAGE WAS FOUND IN THE RETENTION SAMPLE. THE EXACT ROOT CAUSE CAN ONLY BE DETERMINED IF WE RECEIVE THE ORIGINAL SAMPLE.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS BAWAL. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1., AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. E.1. INITIAL REPORTER ADDR 1: (B)(6). H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD DISCARDIT¿ II - 2-PIECE SYRINGE NEEDLE LEAKAGE OCCURRED. THIS OCCURRED TWICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE DRAWING BLOOD WITH DISCARDIT 5ML 23G NEEDLE THERE WERE LEAKAGE BETWEEN BARREL AND PLUNGER BECAUSE OF THAT BLOOD SPILLED OUT FROM BACK OF SYRINGE. IT HAS HAPPENED IN 2 SYRINGES. IT WAS SECOND INCIDENT. PREVIOUSLY IT WAS HAPPENED WITH DISCARDIT 5ML 22G (PIR: 3031772). PATHOLOGIST WAS SAYING INCIDENTS ARE HAPPENING FREQUENTLY NOW A DAYS. AS THIS IS SECOND INCIDENT BACK TO BACK WITH 3 MONTHS. PREVIOUSLY SCEANARIO WAS NOT LIKE THIS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD DISCARDIT¿ II - 2-PIECE SYRINGE NEEDLE LEAKAGE OCCURRED. THIS OCCURRED TWICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE DRAWING BLOOD WITH DISCARDIT 5ML 23G NEEDLE THERE WERE LEAKAGE BETWEEN BARREL AND PLUNGER BECAUSE OF THAT BLOOD SPILLED OUT FROM BACK OF SYRINGE. IT HAS HAPPENED IN 2 SYRINGES. IT WAS SECOND INCIDENT. PREVIOUSLY IT WAS HAPPENED WITH DISCARDIT 5ML 22G (PIR: 3031772). PATHOLOGIST WAS SAYING INCIDENTS ARE HAPPENING FREQUENTLY NOW A DAYS. AS THIS IS SECOND INCIDENT BACK TO BACK WITH 3 MONTHS. PREVIOUSLY SCENARIO WAS NOT LIKE THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978995 BD DISCARDIT¿ II - 2-PIECE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON 2277715

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown