BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE

    MDR report key: 8412337 · Received March 12, 2019

    Report

    Report Number
    1213809-2019-00319
    Event Type
    Malfunction
    Date Received
    March 12, 2019
    Date of Event
    February 25, 2019
    Report Date
    May 10, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903010738
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THIRTY-FOUR LOOSE 3ML SYRINGES WERE RECEIVED AND VISUALLY EVALUATED. IT WAS OBSERVED ON ALL SAMPLES THE SCALE WAS SLIGHTLY ROLLED TO THE RIGHT BUT STILL WITHIN ACCEPTABLE LIMITS PER PRODUCT SPECIFICATION. ROOT CAUSE NOT DEFINED SINCE DEFECTS WERE NOT CONFIRMED IN SAMPLES RECEIVED. NO CORRECTIVE ACTIONS RECOMMENDED SINCE PRODUCT DEFECT WAS NOT CONFIRMED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE TWO PROVIDED LOT NUMBER(S) THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD LUER-LOK¿ SYRINGE HAD SCALE MARKING ISSUES. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. "I WOULD LIKE TO REPORT A COMPLAINT FROM ONE OF OUR CUSTOMERS ABOUT THE 3 ML SYRINGE. PART NUMBER 301073 BATCH 6206718/8090720 THE CUSTOMER REPORTS THAT THE BARS OF THE MEASUREMENT SCALE HAVE NOT BEEN PRINTED HORIZONTALLY ON THE SYRINGE. THE SYRINGES HAVE NOT BEEN USED YET."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6206718. MEDICAL DEVICE EXPIRATION DATE: 2021-07-31. DEVICE MANUFACTURE DATE: 2016-07-24. MEDICAL DEVICE LOT #: 8090720. MEDICAL DEVICE EXPIRATION DATE: 2023-03-31. DEVICE MANUFACTURE DATE: 2018-03-31. (B)(6). 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 · 1

    IT WAS REPORTED THAT BD LUER-LOK¿ SYRINGE HAD SCALE MARKING ISSUES. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. "I WOULD LIKE TO REPORT A COMPLAINT FROM ONE OF OUR CUSTOMERS ABOUT THE 3 ML SYRINGE. PART NUMBER 301073 BATCH 6206718/8090720. THE CUSTOMER REPORTS THAT THE BARS OF THE MEASUREMENT SCALE HAVE NOT BEEN PRINTED HORIZONTALLY ON THE SYRINGE. THE SYRINGES HAVE NOT BEEN USED YET."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205359 BD LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 00382903010738

    Patients

    Seq Age Sex Outcome Treatment
    1 Other