BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL S/C 56

    MDR report key: 17949779 · Received October 17, 2023

    Report

    Report Number
    1911916-2023-00781
    Event Type
    Malfunction
    Date Received
    October 17, 2023
    Date of Event
    October 15, 2023
    Report Date
    November 2, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903028321
    PMA / PMN Number
    K110771
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL. INFORMATION BECOMES AVAILABLE. DEVICE PROBLEM CODE: A0401 - BREAK. PATIENT PROBLEM CODE: F27 ¿ NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED THE LUER IS FLAWED. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER AND TWO PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. FIRST, WITH 10X MAGNIFICATION AND THEN WITH 30X MAGNIFICATION. THE SYRINGE BARREL LUER TIP HAS AN ACCEPTABLE IMPERFECTION. THE TWO PHOTOS PROVIDED SHOW THE SAMPLE RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOT 2243878. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. HOWEVER, THIS IS AN ACCEPTABLE IMPERFECTION.

    Additional Manufacturer Narrative · 0

    UPDATE FOR CODING (B)(4) FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED THE LUER IS FLAWED. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER AND TWO PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. FIRST, WITH 10X MAGNIFICATION AND THEN WITH 30X MAGNIFICATION. THE SYRINGE BARREL LUER TIP HAS AN ACCEPTABLE IMPERFECTION. THE TWO PHOTOS PROVIDED SHOW THE SAMPLE RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOT 2243878. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. HOWEVER, THIS IS AN ACCEPTABLE IMPERFECTION.

    Description of Event or Problem · 0

    LUER FAULTY, NOT SMOOTH AND FLAWED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED LUER FAULTY, NOT SMOOTH AND FLAWED

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. LUER FAULTY, NOT SMOOTH AND FLAWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82995 SYRINGE 30ML LL S/C 56 SYRINGE, PISTON FMF BECTON DICKINSON 2243878 30382903028321

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown