BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL S/C 56

    MDR report key: 20673735 · Received November 13, 2024

    Report

    Report Number
    1911916-2024-00805
    Event Type
    Malfunction
    Date Received
    November 13, 2024
    Date of Event
    November 11, 2024
    Report Date
    December 10, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THERE IS A MILKY SUBSTANCE ON THE BLACK OF THE PLUNGER. TO AID IN THE INVESTIGATION, TWO SAMPLES AND ONE PHOTO WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. ONE SAMPLE CAME IN A SEALED PACKAGING BLISTER AND ONE SAMPLE CAME WITH NO PACKAGING BLISTER. A VISUAL INSPECTION WAS PERFORMED, AND THERE WERE NO DEFECTS OR IMPERFECTIONS. NO EXCESS OF SILICONE WAS OBSERVED. THE PHOTO PROVIDED SHOWS A SYRINGE OUT OF THE PACKAGING BLISTER AND THE PLUNGER ROD PULLED BACK. THE SYRINGE PLUNGER ROD RUBBER STOPPER HAS WHAT APPEARS TO BE A DROPLET OF LUBRICANT AT THE CENTER. HOWEVER, IT IS NOT CLEAR FROM THE PHOTO IF IT IS LUBRICANT, OR LIGHT REFLECTED ON THAT SPOT. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOT 4152403. 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 COULD NOT BE CONFIRMED.

    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. IT WAS REPORTED THERE IS A MILKY SUBSTANCE ON THE BLACK OF THE PLUNGER. TO AID IN THE INVESTIGATION, TWO SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. ONE SAMPLE CAME IN A SEALED PACKAGING BLISTER AND ONE SAMPLE CAME WITH NO PACKAGING BLISTER. A VISUAL INSPECTION WAS PERFORMED, AND THERE WERE NO DEFECTS OR IMPERFECTIONS. NO EXCESS OF SILICONE WAS OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOT 4152403. 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 COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Description of Event or Problem · 0

    MAT#302832 LOT#4152403 SEVERAL OF THE SYRINGES HAVE A MILKY SUBSTANCE ON THE BLACK OF THE PLUNGER (INSIDE THE SYRINGE) CUSTOMER HAS SAMPLE TO RETURN AND NOTICED (B)(4) TOTAL. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2306892 SYRINGE 30ML LL S/C 56 SYRINGE, PISTON FMF BECTON DICKINSON 4152403

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown