BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGE

    MDR report key: 13256490 · Received January 13, 2022

    Report

    Report Number
    1213809-2022-00001
    Event Type
    Malfunction
    Date Received
    January 13, 2022
    Date of Event
    December 15, 2021
    Report Date
    January 24, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: LOT #: 0196149, DEVICE EXPIRATION DATE: 06/30/2025, DEVICE MANUFACTURE DATE: 07/14/2020, LOT #: 0198845, DEVICE EXPIRATION DATE: 06/30/2025, DEVICE MANUFACTURE DATE: 07/16/2020, LOT #: 0199099, DEVICE EXPIRATION DATE: 06/30/2025, DEVICE MANUFACTURE DATE: 07/17/2020, LOT #: 0280504, DEVICE EXPIRATION DATE: 09/30/2025, DEVICE MANUFACTURE DATE: 10/06/2020, LOT #: 1173067, DEVICE EXPIRATION DATE: 05/31/2026, DEVICE MANUFACTURE DATE: 06/22/2021, LOT #: 1180401, DEVICE EXPIRATION DATE: 06/30/2026, DEVICE MANUFACTURE DATE: 06/29/2021. 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

    INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. UNUSED PHYSICAL SAMPLES FROM THE COMPLAINT BATCHES ARE NEEDED TO DETERMINE IF THE DEFECT IS PRESENT AND TO PERFORM LEAKAGE TESTING. THERE HAVE BEEN NO CHANGES TO THIS PRODUCT IN THE LAST 2 YEARS AND NO OPEN RECALLS FOR THIS PRODUCT CURRENTLY. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 6 BD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGES LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED THE 301027 SYRINGE (5ML LUER-LOCK) FOR LEAKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 6 BD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGES LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED THE 301027 SYRINGE (5ML LUER-LOCK) FOR LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833742 BD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown