BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL 200 S/C

    MDR report key: 12930024 · Received December 3, 2021

    Report

    Report Number
    1213809-2021-00797
    Event Type
    Malfunction
    Date Received
    December 3, 2021
    Date of Event
    November 5, 2021
    Report Date
    December 30, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 0003854. D4: MEDICAL DEVICE EXPIRATION DATE: 2024-12-31. H4: DEVICE MANUFACTURE DATE: 2020-01-03. D4: MEDICAL DEVICE LOT #: 7267907. D4: MEDICAL DEVICE EXPIRATION DATE: 2022-09-30. H4: DEVICE MANUFACTURE DATE: 2017-09-24. D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-12-20. H6: INVESTIGATION SUMMARY: ONE PHOTO AND THREE HUNDRED AND TEN 3ML SYRINGES (P/N 309657) SEALED IN THEIR BLISTERPACKS WERE RECEIVED. THE SAMPLES WERE VISUALLY EVALUATED. ONE SAMPLE WAS FOUND TO BE FROM BATCH #7267907, AND TWO WERE FROM #0003854, WITH THE REST FROM BATCH #1140702. NO DAMAGE TO THE LUER OR COLLAR AREA WAS OBSERVED ON ANY SAMPLES RECEIVED THAT WOULD LEAD TO THE LEAKAGE OR CONNECTION ISSUES DESCRIBED. PHYSICAL SAMPLES THAT DISPLAY THE DEFECT CLEARLY ARE NEEDED TO CONFIRM ITS PRESENCE. ALL SYRINGES RECEIVED WERE ACCEPTABLE PER PRODUCT SPECIFICATION. SINCE THE SAMPLES RECEIVED DID NOT DISPLAY THE REPORTED CONDITION A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED, AND CORRECTIVE ACTIONS ARE NOT NECESSARY. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 3ML LL 200 S/C LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT :LEAKAGE FROM A SYRINGE SENT TO NICU. "

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 3ML LL 200 S/C LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT :LEAKAGE FROM A SYRINGE SENT TO NICU. "

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 3ML LL 200 S/C LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT :LEAKAGE FROM A SYRINGE SENT TO NICU. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820742 BD SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 SEE H10 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown