BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML REG PR SALINE 10ML FILL

    MDR report key: 18147884 · Received November 16, 2023

    Report

    Report Number
    1911916-2023-00845
    Event Type
    Malfunction
    Date Received
    November 16, 2023
    Date of Event
    October 17, 2023
    Report Date
    December 5, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    30382903065463
    PMA / PMN Number
    K003553
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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. PATIENT PROBLEM CODE: F27 ¿ NO PATIENT INVOLVEMENT DEVICE PROBLEM CODE: A180104 - DEVICE CONTAMINATION WITH CHEMICAL OR OTHER MATERIAL

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THERE IS A WHITE POWDER LIKE SUBSTANCE FOUND ON THE LUER LOCK TIP OF THE SYRINGE. TO AID IN THE INVESTIGATION, ONE SAMPLE WITH NO PACKAGING FLOW WRAP AND ELEVEN PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. FIRST, WITH 10X MAGNIFICATION, AND THEN WITH A 30X MICROSCOPE. NO FOREIGN MATTER OF ANY KIND WAS OBSERVED. THE ELEVEN PHOTOS PROVIDED SHOW THE SAMPLE RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306546, LOT 3031929. 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 AND A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED. IT WAS REPORTED THE WHITE CAP WAS FOUND DEFORMED WHEN OPENED FOR USE AND HAD DIRT ON IT. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER FLOW WRAP AND ELEVEN PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. THE TIP CAP IS DAMAGE AND HAS TWO SPOTS OF FOREIGN MATTER THAT IS RUST FROM THE STERILIZATION TRAYS. THE ELEVEN PHOTOS PROVIDED SHOW THE SAMPLE RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THE SYRINGE WAS MISPLACED ON THE STERILIZATION FIXTURE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306546, LOT 2354494. 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.

    Description of Event or Problem · 0

    COMPLAINT FROM HOSPITAL. THE CUSTOMER COMPLAINED THAT : 1) FOR LOT NO. 3031929, WHITE POWDER LIKE SUBSTANCE/SCAR WAS FOUND ON LUER LOCK TIP OF THE SYRINGE. 2) FOR LOT NO. 2354494, THE WHITE STOPPER WAS FOUND DEFORMED WHEN OPENED FOR USE. AND OBVIOUS DIRT WAS FOUND ON IT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. COMPLAINT FROM HOSPITAL. THE CUSTOMER COMPLAINED THAT : 1) FOR LOT NO. 3031929, WHITE POWDER LIKE SUBSTANCE/SCAR WAS FOUND ON LUER LOCK TIP OF THE SYRINGE. 2) FOR LOT NO. 2354494, THE WHITE STOPPER WAS FOUND DEFORMED WHEN OPENED FOR USE. AND OBVIOUS DIRT WAS FOUND ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1584212 SYRINGE 10ML REG PR SALINE 10ML FILL SALINE, VASCULAR ACCESS FLUSH FOZ BECTON DICKINSON 2354494 30382903065463
    237658 SYRINGE 10ML REG PR SALINE 10ML FILL SALINE, VASCULAR ACCESS FLUSH FOZ BECTON DICKINSON 2354494 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown