BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGE

    MDR report key: 15498858 · Received September 28, 2022

    Report

    Report Number
    1213809-2022-00648
    Event Type
    Malfunction
    Date Received
    September 28, 2022
    Date of Event
    September 7, 2022
    Report Date
    October 11, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: TWO PHOTOS WERE RECEIVED AND EVALUATED. THE PHOTOS BOTH APPEARED TO BE IDENTICALLY DISPLAYING A PLUNGER'S STOPPER ASSEMBLY (P/N 301027). A LIQUID SUBSTANCE WAS PRESENT ON THE STOPPER FACE. THE LIQUID APPEARED TO BE SILICONE LUBRICANT NORMALLY USED IN THE MANUFACTURING PROCESS, OF WHICH THE NORMAL EXPECTED AMOUNT WAS PRESENT. THE PRODUCT AS SHOWN WAS ACCEPTABLE PER PRODUCT SPECIFICATION. DEVICE HISTORY REVIEW: RELEASE DATE: 06/18/2022. RELEASED QUANTITY WAS (B)(4) ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH #2152955 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGE EXPERIENCED WET SUBSTANCE ON THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CLAIMS AFTER SEVERAL USES THEY NOTICED A WET SUBSTANCE ON THE SYRINGE PLUNGER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGE EXPERIENCED WET SUBSTANCE ON THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CLAIMS AFTER SEVERAL USES THEY NOTICED A WET SUBSTANCE ON THE SYRINGE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1747749 BD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2152955

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown