BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML REG PR SALINE 10ML FILL

    MDR report key: 22115210 · Received May 30, 2025

    Report

    Report Number
    1911916-2025-00387
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    May 2, 2025
    Report Date
    June 10, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    30382903065463
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION: A REPORT WAS RECEIVED INDICATING THAT SEVERAL BD SALINE SYRINGES HAD BACKFIRED. TO SUPPORT THE INVESTIGATION, EIGHT SYRINGE SAMPLES AND ONE PHOTOGRAPH WERE SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. OF THE EIGHT SAMPLES, SIX WERE RECEIVED IN SEALED FLOW WRAP PACKAGING, WHILE TWO ARRIVED UNPACKAGED AND WITHOUT TIP CAPS. A VISUAL INSPECTION WAS CONDUCTED ON ALL SAMPLES, AND NO DEFECTS OR ABNORMALITIES WERE OBSERVED. FOR THE SIX SEALED SAMPLES, THE SOLUTION WAS SUCCESSFULLY EXPELLED WITHOUT ANY LEAKAGE PAST THE STOPPER. THE ACCOMPANYING PHOTOGRAPH DEPICTS TWO OF THE SUBMITTED SAMPLES. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR MATERIAL NUMBER 306546, LOT 5024225. THE REVIEW FOUND NO QUALITY ISSUES DURING THE MANUFACTURING PROCESS THAT COULD BE LINKED TO THE REPORTED MALFUNCTION. ADDITIONALLY, THERE WERE NO ASSOCIATED QUALITY NOTIFICATIONS. ALL PRODUCTION PROCESSES AND FINAL INSPECTIONS WERE CONDUCTED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. TO DATE, NO SIMILAR INCIDENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE RETURNED SAMPLE ANALYSIS AND THE FINDINGS OF THE INVESTIGATION, THE REPORTED ISSUE COULD NOT BE REPLICATED, AND A PROBABLE ROOT CAUSE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    MATERIAL #: 306546 BATCH #: 5024225. IT WAS REPORTED BY CUSTOMER THAT THEY HAD A COUPLE OF BD SALINE SYRINGES BACKFIRE. THE SALINE SHOT OUT OF THE BACK OF THE SYRINGE WHERE THE PLUNGER IS. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I¿M NOT SURE IF THIS WOULD BE FOR YOU BUT WE RECENTLY HAD A COUPLE OF BD SALINE SYRINGES BACKFIRE. COULD YOU PLEASE PROVIDE A DETAILED EXPLANATION OF WHAT IS MEANT BY 'BACKFIRE' IN THIS CONTEXT? DOES THE TERM REFER TO LEAKAGE? ADDITIONALLY, WAS THERE ANY PHYSICAL DAMAGE OBSERVED ON THE SYRINGE? THE SALINE SHOT OUT OF THE BACK OF THE SYRINGE WHERE THE PLUNGER IS. PLEASE PROVIDE THE BATCH # OR LOT # NUMBER? 5024225 PLEASE SHARE THE CAPTURED PHOTO OF THE EVENT IF AVAILABLE. ATTACHED. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO HARM OR INJURY IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579312 SYRINGE 10ML REG PR SALINE 10ML FILL SALINE, VASCULAR ACCESS FLUSH FOZ BECTON DICKINSON 5024225 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown