BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 19414594 · Received May 29, 2024

    Report

    Report Number
    1911916-2024-00388
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Date of Event
    May 16, 2024
    Report Date
    June 6, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    PR (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THERE WERE ARTIFACTS IN THE PLASTIC. TO AID IN THE INVESTIGATION, TWO SAMPLES AND TWO PHOTOS WERE PROVIDED 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 BOTH SAMPLES HAVE A WHITE SPECK EMBEDDED IN THE SYRINGE BARREL. THE TWO PHOTOS PROVIDED SHOW ONE OF THE SAMPLES RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE EMBEDDED DEGRADED RESIN IN THE COMPONENT TYPICALLY OCCURS AT THE STARTUP OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT 2153766. 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. THE SAMPLES WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. 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.

    Description of Event or Problem · 0

    MATERIALS#: 309653 BATCH#: 2153766 IT WAS REPORTED BY THE CUSTOMER THAT WE¿VE FOUND ABOUT A DOZEN RXH 317694 BD 50ML SYRINGES IN THE PAST WEEK THAT HAVE DISCOLORATION / ARTIFACTS IN THE PLASTIC (WHITE SPOT IN PHOTO). VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED WE¿VE FOUND ABOUT A DOZEN RXH 317694 BD 50ML SYRINGES IN THE PAST WEEK THAT HAVE DISCOLORATION / ARTIFACTS IN THE PLASTIC (WHITE SPOT IN PHOTO). ALL FROM THE SAME LOT/EXP PICTURED BELOW. CAN YOU PLEASE FOLLOW UP WITH THE MANUFACTURER TO ALERT THEM? ADDITIONAL INFORMATION: 1. ARE YOU ABLE TO PROVIDE THE DATES OF THE EVENTS IN THE FORMAT OF MM-DD-YYYY? IF UNKNOWN, CAN STATE UNKNOWN. A. DISCOVERED 05-16-2024 2. HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? A. AS OF TODAY, WE HAVE NOT RECEIVED ANY REPORTS OF ADVERSE PATIENT IMPACT 3. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTH CARE PROFESSIONAL? A. AS OF TODAY, WE HAVE NOT RECEIVED ANY REPORTS OF ADVERSE PATIENT IMPACT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. MATERIALS#: 309653 BATCH#: 2153766. IT WAS REPORTED BY THE CUSTOMER THAT WE¿VE FOUND ABOUT A DOZEN RXH 317694 BD 50ML SYRINGES IN THE PAST WEEK THAT HAVE DISCOLORATION / ARTIFACTS IN THE PLASTIC (WHITE SPOT IN PHOTO). VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE¿VE FOUND ABOUT A DOZEN RXH 317694 BD 50ML SYRINGES IN THE PAST WEEK THAT HAVE DISCOLORATION / ARTIFACTS IN THE PLASTIC (WHITE SPOT IN PHOTO). ALL FROM THE SAME LOT/EXP PICTURED BELOW. CAN YOU PLEASE FOLLOW UP WITH THE MANUFACTURER TO ALERT THEM?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1884782 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 2153766 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown