BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL 200 S/C

    MDR report key: 10932359 · Received December 2, 2020

    Report

    Report Number
    1213809-2020-00857
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    October 28, 2020
    Report Date
    December 14, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 SYRINGES 3ML LL 200 S/C EXPERIENCED THE TIP/LUER OF SYRINGE BREAKING OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657. BATCH NO: 9048593, 0015492. INCIDENT DATE (B)(6) 2020. ATTEMPTED ADMINISTRATION OF TWO SYRINGES, IN THE SECOND SYRINGE THE SYRINGE FAILED DUE TO LUR LOCK COMING OFF OF THE SYRINGE ALONG WITH NEEDLE. GAVE TWO LOT #'S AS THE CONSUMER WAS NOT SURE WHICH LOT THE SYRINGE CAME FROM.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9048593 (INVALID LOT #), MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: NA. MEDICAL DEVICE LOT #: 0015492, MEDICAL DEVICE EXPIRATION DATE: 2025-01-31, DEVICE MANUFACTURE DATE: 2020-05-02. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 SYRINGES 3ML LL 200 S/C EXPERIENCED THE TIP/LUER OF SYRINGE BREAKING OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657 BATCH NO: 9048593, 0015492. INCIDENT DATE (B)(6) 2020. ATTEMPTED ADMINISTRATION OF TWO SYRINGES, IN THE SECOND SYRINGE THE SYRINGE FAILED DUE TO LUR LOCK COMING OFF OF THE SYRINGE ALONG WITH NEEDLE. GAVE TWO LOT #'S AS THE CONSUMER WAS NOT SURE WHICH LOT THE SYRINGE CAME FROM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398998 SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 SEE H10 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1