BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL S/C 56

    MDR report key: 19117308 · Received April 16, 2024

    Report

    Report Number
    1911916-2024-00264
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    March 18, 2024
    Report Date
    May 1, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903028321
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR 10047810 FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED THE TIP OF SYRINGE HAS DEBRIS. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THE SYRINGE BARREL LUER HAS BLACK SPECK OF EMBEDDED DEGRADED RESIN. INSIDE AND ADHERED TO THE BARREL LUER TIP THERE IS ALSO A PARTICLE OF BURNT RESIN THAT IS ABOUT 1/16" IN SIZE. THE PHOTO PROVIDED SHOWS THE SAMPLE 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 302832, LOT 3333859. 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 SAMPLE 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.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED MATERIAL# 302832 BATCH# 3333859 IT WAS REPORTED BY CUSTOMER THAT THE LUER LOCK TIP OF SYRINGE HAS BLACK SPOT/DEBRIS. VERBATIM: EVENT DATE: 3-18-2024 EVENT LOCATION: (B)(6). EVENT DESCRIPTION: ¿LUER LOCK TIP OF SYRINGE HAS BLACK SPOT/DEBRIS.¿ HARM TO TEAM MEMBER OR PATIENT? NO INJURY. PRODUCT NAME: ITM-1120007 - SYRINGE 30ML LUER LOC TIP PRODUCT REF: 302832 LOT NUMBER: 3333859 BD CUSTOMER ACCOUNT NUMBER: 1001031612 PHOTO OF SYRINGE IS ATTACHED. PRODUCT IS AVAILABLE TO RETURN FOR EVALUATION IF NEEDED.

    Description of Event or Problem · 0

    MATERIAL# 302832 BATCH# 3333859. IT WAS REPORTED BY CUSTOMER THAT THE LUER LOCK TIP OF SYRINGE HAS BLACK SPOT/DEBRIS. VERBATIM: EVENT DATE: 3-18-2024 EVENT DESCRIPTION: ¿LUER LOCK TIP OF SYRINGE HAS BLACK SPOT/DEBRIS.¿ HARM TO TEAM MEMBER OR PATIENT? NO INJURY. PRODUCT NAME: ITM-1120007 - SYRINGE 30ML LUER LOC TIP. PRODUCT REF: 302832. LOT NUMBER: 3333859. PHOTO OF SYRINGE IS ATTACHED. PRODUCT IS AVAILABLE TO RETURN FOR EVALUATION IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333663 SYRINGE 30ML LL S/C 56 SYRINGE, PISTON FMF BECTON DICKINSON 3333859 30382903028321

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown