BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML REG PR SALINE 10ML FILL

    MDR report key: 18236404 · Received November 30, 2023

    Report

    Report Number
    1911916-2023-00868
    Event Type
    Malfunction
    Date Received
    November 30, 2023
    Date of Event
    November 13, 2023
    Report Date
    January 24, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    30382903065463
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THERE IS A DRIED RED SUBSTANCE ON THE HUB OF THE SYRINGE. TO AID IN THE INVESTIGATION, FIFTY-NINE SAMPLES IN SEALED PACKAGING FLOW WRAPS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS, IMPERFECTIONS OR FOREIGN MATTER OF ANY KIND WAS OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306546, LOT 3142760. 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. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. DEVICE PROBLEM CODE: A180104 - DEVICE CONTAMINATION WITH CHEMICAL OR OTHER MATERIAL PATIENT PROBLEM CODE: F27 ¿ NO PATIENT INVOLVEMENT

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED. I UPLOADED TWO SETS OF PICTURES PRIOR. NO PATIENT WAS REACHED BY THESE. THEY WERE DISCOVERED WHEN PHARMACY WAS LOADING THEM OUT ON THE UNITS. THE NDC IS 08290-3065-46 LOT 3142760. WE SENT BACK THE FIRST FEW AND HAVE 2 MORE BOXES WAITING FOR YOUR PREPAID SHIPPING LABEL. IT APPEARS THAT THERE IS A DRIED RED SUBSTANCE ON THE HUB OF THE LUER LOCK SYRINGE. TO DATE, WE HAVE DISCOVERED 3 TOTAL SYRINGES THIS WAY. WE DID SEPARATE ALL SYRINGES WITH THAT LOT AND ARE JUST WAITING ON YOU ALL FOR A SHIPPING LABEL. ONCE AGAIN, NO PATIENT IMPACT. MATERIAL #: 306546, BATCH#: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT RECENTLY HAD 2 MORE SYRINGES THAT LOOK EXACTLY THE SAME WAY. DO I NEED TO QUARANTINE THE WHOLE BOX? DID YOU ALL EVER SEND OUT A RECALL? I AM STARTING TO GET UNCOMFORTABLE WITH THESE FLUSHES. VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. I RECENTLY HAD 2 MORE SYRINGES THAT LOOK EXACTLY THE SAME WAY. DO I NEED TO QUARANTINE THE WHOLE BOX? DID YOU ALL EVER SEND OUT A RECALL? I AM STARTING TO GET UNCOMFORTABLE WITH THESE FLUSHES.

    Description of Event or Problem · 0

    MATERIAL #: 306546 BATCH#: UNKNOWN IT WAS REPORTED BY CUSTOMER THAT RECENTLY HAD 2 MORE SYRINGES THAT LOOK EXACTLY THE SAME WAY. DO I NEED TO QUARANTINE THE WHOLE BOX? DID YOU ALL EVER SEND OUT A RECALL? I AM STARTING TO GET UNCOMFORTABLE WITH THESE FLUSHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1845253 SYRINGE 10ML REG PR SALINE 10ML FILL SALINE, VASCULAR ACCESS FLUSH FOZ BECTON DICKINSON 3142760 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown