BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD SYRINGE

    MDR report key: 17597737 · Received August 22, 2023

    Report

    Report Number
    2243072-2023-01486
    Event Type
    Malfunction
    Date Received
    August 22, 2023
    Date of Event
    July 27, 2023
    Report Date
    August 29, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: AS NO PHYSICAL SAMPLE, VALID PART NUMBER OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. 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. 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 AN UNSPECIFIED BD SYRINGE THE PLUNGER FELL OUT. THIS IS REPORT 6 OF 6. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE CONTINUE TO SEE ISSUES IN ONE AREA OF OUR HOSPITAL (ALL DIFFERENT STAFF INVOLVED)AND THE PLUNGER IS REMOVED WHEN THE TAMPER PACKAGING IS OPENED. EDUCATION/VIDEOS/ROUNDS HAVE BEEN COMPLETED AS WELL, RE: PROPERLY OPENING THE PACKAGING. 15 AUG 23 -COULD YOU PLEASE ADVISE THE OCCURRENCE DATE? 4/24/23, 5/2/23, 6/16/23, 6/20/23, 6/29/23, 7/27/23 -WHAT IS THE MATERIAL AND BATCH NUMBER OF THE AFFECTED PRODUCT? UNSURE-@XXXX? -IS THERE ANY ADVERSE EVENT ON PATIENT? NO. -DO YOU HAVE PHOTO OF THE FAULTY PRODUCT? NO. -IS SAMPLE AVAILABLE FOR RETURN? IF YES, PLEASE PROVIDE ADDRESS FOR RETURN LABEL. NO. -I DO NOT HAVE ANY BATCH NUMBERS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING AN UNSPECIFIED BD SYRINGE THE PLUNGER FELL OUT. THIS IS REPORT 6 OF 6. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE CONTINUE TO SEE ISSUES IN ONE AREA OF OUR HOSPITAL (ALL DIFFERENT STAFF INVOLVED)AND THE PLUNGER IS REMOVED WHEN THE TAMPER PACKAGING IS OPENED. EDUCATION/VIDEOS/ROUNDS HAVE BEEN COMPLETED AS WELL, RE: PROPERLY OPENING THE PACKAGING. 15 AUG 23 -COULD YOU PLEASE ADVISE THE OCCURRENCE DATE?(B)(6) 2023. -WHAT IS THE MATERIAL AND BATCH NUMBER OF THE AFFECTED PRODUCT? UNSURE? -IS THERE ANY ADVERSE EVENT ON PATIENT? NO. -DO YOU HAVE PHOTO OF THE FAULTY PRODUCT? NO. -IS SAMPLE AVAILABLE FOR RETURN? IF YES, PLEASE PROVIDE ADDRESS FOR RETURN LABEL. NO. -I DO NOT HAVE ANY BATCH NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56786 UNSPECIFIED BD SYRINGE PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown