BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL S/C 48

    MDR report key: 19287611 · Received May 10, 2024

    Report

    Report Number
    1911916-2024-00346
    Event Type
    Malfunction
    Date Received
    May 10, 2024
    Date of Event
    April 26, 2024
    Report Date
    May 24, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    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 (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THERE WAS A RED BROWN SUBSTANCE ON THE END OF THE SYRINGE. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THE SYRINGE PLUNGER ROD THUMB PRESS HAS LUBRICANT FROM THE MOLDING PROCESS. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF, DURING A MOLDING REPAIR, RESIDUES OF LUBRICANT WERE LEFT INDUCING THE SYMPTOM REPORTED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830, LOT 4059791. 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. H3 OTHER TEXT: SEE H10 MANUFACTURE NARRATIVE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED. HOW OCCURRENCES YOU HAVE ENCOUNTERED SO FAR? TO DATE, 1 OCCURRENCE WITH THIS LOT. WHEN WAS IT DISCOVERED? (BEFORE/AFTER USE) BEFORE USE. MATERIAL#: 302830 BATCH#: 4059791. IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE OPENED A 20ML LUER LOK SYRINGE TO DRAW UP MEDICATIONS. SEAL WAS INTACT SO THE SYRINGE WAS "STERILE", BUT THERE WAS QUESTIONABLE RED/BROWN SUBSTANCE ON THE SYRINGE END (THEREFORE CONTAMINATED). VERBATIM: EVENT DATE: 4-26-2024. EVENT LOCATION: XXXXXXXXXXXXXXXXXX EVENT DESCRIPTION: ¿20 ML LUER-LOK TIP SYRINGE OPENED TO DRAW UP MEDICATIONS. SEAL WAS INTACT SO THE SYRINGE WAS "STERILE", BUT THERE WAS QUESTIONABLE RED/BROWN SUBSTANCE ON THE SYRINGE END (THEREFORE CONTAMINATED).¿ HARM TO TEAM MEMBER OR PATIENT? NO INJURY. PRODUCT NAME: ITM-1120080 - SYRINGE 20ML LUER LOC TIP. PRODUCT REF: 302830. LOT NUMBER: 4059791. BD CUSTOMER ACCOUNT NUMBER: (B)(6). NO PHOTO OR SAMPLE AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    MATERIAL#: 302830 BATCH#: 4059791. IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE OPENED A 20ML LUER LOK SYRINGE TO DRAW UP MEDICATIONS. SEAL WAS INTACT SO THE SYRINGE WAS "STERILE", BUT THERE WAS QUESTIONABLE RED/BROWN SUBSTANCE ON THE SYRINGE END (THEREFORE CONTAMINATED) EVENT DATE: 4-26-2024. EVENT LOCATION: XXXXXXXXXXXXXXXXXX. EVENT DESCRIPTION: ¿20 ML LUER-LOK TIP SYRINGE OPENED TO DRAW UP MEDICATIONS. SEAL WAS INTACT SO THE SYRINGE WAS "STERILE", BUT THERE WAS QUESTIONABLE RED/BROWN SUBSTANCE ON THE SYRINGE END (THEREFORE CONTAMINATED).¿ HARM TO TEAM MEMBER OR PATIENT? NO INJURY. PRODUCT NAME: ITM-1120080 - SYRINGE 20ML LUER LOC TIP. PRODUCT REF: 302830. LOT NUMBER: 4059791. BD CUSTOMER ACCOUNT NUMBER: (B)(6). NO PHOTO OR SAMPLE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742507 SYRINGE 20ML LL S/C 48 SYRINGE, PISTON FMF BECTON DICKINSON 4059791

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown