BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL BNS

    MDR report key: 18118502 · Received November 13, 2023

    Report

    Report Number
    1911916-2023-00840
    Event Type
    Malfunction
    Date Received
    November 13, 2023
    Date of Event
    November 3, 2023
    Report Date
    December 7, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    50382903010313
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR 9190871: INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. PATIENT PROBLEM CODE: F26 ¿ NO HEALTH CONSEQUENCES OR IMPACT. DEVICE PROBLEM CODE: A0202 - DEFECTIVE COMPONENT. 3 BATCH NUMBERS PROVIDED FOR ONE EVENT; THEREFORE, LOT IS UNKNOWN. POSSIBLE BATCH NUMBERS ARE AS FOLLOWS: 2152904, 2032044, 2032048.

    Additional Manufacturer Narrative · 0

    PR 9190871 FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THE STOPPER IN THE SYRINGE LOOKS DAMAGED. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. TO AID IN THE INVESTIGATION, SEVEN PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW TWO SYRINGES. ONE IS LABELED CONTROL SAMPLE, AND THE OTHER SYRINGE HAS A DEFECTIVE STOPPER THAT APPEARS TO BE MISSING A PIECE FROM THE TOP PART OF THE COMPONENT. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301031, POSSIBLE LOTS 2152904, 2032044 AND 2032048. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH OUR SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THESE LOTS. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED, BUT WITHOUT THE PHYSICAL SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    MATERIAL#: 301031, BATCH#: 2152904. IT WAS REPORTED BY THE CUSTOMER THAT THE SYRINGE FROM THE REFILL KIT WAS NOT AIRTIGHT WHEN EMPTYING THE WATER FROM A NEW PUMP. THE BLACK AIR LOCK IN THE SYRINGE LOOKS DAMAGED. IT WAS REPORTED THAT DUE TO THIS, AIR ENTERED THE PUMP. THERE WERE NO ENVIRONMENTAL, EXTERNAL, PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE DIAGNOSTICS/TROUBLESHOOTING AND ACTIONS/INTERVENTIONS TAKEN TO RESOLVE THE ISSUE WAS A NEW SYRINGE WAS USED AND THE AIR WAS EMPTIED FROM THE PUMP. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT AND THE PATIENT'S STATUS WAS "ALIVE-NO INJURY".

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. MATERIAL#: 301031. BATCH#: 2152904. IT WAS REPORTED BY THE CUSTOMER THAT THE SYRINGE FROM THE REFILL KIT WAS NOT AIRTIGHT WHEN EMPTYING THE WATER FROM A NEW PUMP. THE BLACK AIR LOCK IN THE SYRINGE LOOKS DAMAGED. IT WAS REPORTED THAT DUE TO THIS, AIR ENTERED THE PUMP. THERE WERE NO ENVIRONMENTAL, EXTERNAL, PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE DIAGNOSTICS/TROUBLESHOOTING AND ACTIONS/INTERVENTIONS TAKEN TO RESOLVE THE ISSUE WAS A NEW SYRINGE WAS USED AND THE AIR WAS EMPTIED FROM THE PUMP. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT AND THE PATIENT'S STATUS WAS "ALIVE-NO INJURY". VERBATIM: DAMAGED PLUNGER IN SYRINGE. IT WAS REPORTED THAT THE SYRINGE FROM THE REFILL KIT WAS NOT AIRTIGHT WHEN EMPTYING THE WATER FROM A NEW PUMP. IT WAS REPORTED THAT THE BLACK AIR LOCK IN THE SYRINGE LOOKS DAMAGED. IT WAS REPORTED THAT DUE TO THIS, AIR ENTERED THE PUMP. THERE WERE NO ENVIRONMENTAL, EXTERNAL, PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE DIAGNOSTICS/TROUBLESHOOTING AND ACTIONS/INTERVENTIONS TAKEN TO RESOLVE THE ISSUE WAS A NEW SYRINGE WAS USED AND THE AIR WAS EMPTIED FROM THE PUMP. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT AND THE PATIENT'S STATUS WAS "ALIVE-NO INJURY". IMAGES OF THE ISSUE ARE ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2219942 SYRINGE 20ML LL BNS SYRINGE, PISTON FMF BECTON DICKINSON UNKNOWN 50382903010313

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown