BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL S/C 48

    MDR report key: 21917897 · Received April 28, 2025

    Report

    Report Number
    1911916-2025-00314
    Event Type
    Malfunction
    Date Received
    April 28, 2025
    Date of Event
    April 14, 2025
    Report Date
    May 5, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903028307
    PMA / PMN Number
    K110771
    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

    (B)(4) FOLLOW UP. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 302830 AND LOT NUMBER 4080728. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    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. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Description of Event or Problem · 0

    MATERIAL # 302830, BATCH # 4080728. IT WAS REPORTED BY CUSTOMER THAT "VIAL STOPPER CORING IS REPORTED WHEN ACCESSING BD® BLUNT FILL NEEDLE WITH BD LUER-LOK. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED FRESENIUS KABI USA LLC HAS RECEIVED REPORTS IN WHICH VIAL STOPPER CORING IS REPORTED WHEN ACCESSING FRESENIUS KABI¿S DIPRIVAN WITH: BD® BLUNT FILL NEEDLE WITH BD LUER-LOK¿. THE PRODUCT INFORMATION BELOW IS FOR YOUR REFERENCE IN NO ORDER OR INDICATION TO THE NUMBER OF REPORTS INVOLVED. FRESENIUS KABI IS UNABLE TO PROVIDE FURTHER INFORMATION, SAMPLE RETURNS, PHOTOGRAPHS, OR CUSTOMER RELATED INFORMATION AT THIS TIME. PLEASE CONSIDER ALL INFORMATION WITH NO ACCESS TO FOLLOW-UP INFORMATION. FUTURE REPORTS MAYBE FORWARDED DIRECTLY TO BD FOR FURTHER REVIEW. LOT: UNKNOWN, (B)(4), LOT: 4080728, LOT: 4178014, LOT: 4178027,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1596822 SYRINGE 20ML LL S/C 48 SYRINGE, PISTON FMF BECTON DICKINSON 4080728 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown