BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 16842079 · Received May 1, 2023

    Report

    Report Number
    1213809-2023-00437
    Event Type
    Malfunction
    Date Received
    May 1, 2023
    Date of Event
    February 13, 2023
    Report Date
    May 19, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096282
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 04-MAY-2023. FOUR SAMPLES AND FOUR PHOTOS OF 1ML LUER-LOK SYRINGES (309628) BATCH 9112911 WERE RECEIVED AND EVALUATED. ALL SYRINGE SAMPLES WERE RECEIVED IN SEALED PACKAGES. ONE OF THE SAMPLES HAD MISSING PRINT ON THE 0.5, 0.6, AND 0.7 GRADUATION LINES WITH LESS THAN 50% OF EACH CHARACTER MISSING. ANOTHER SAMPLE IS MISSING PRINT LESS THAN 50% ON THE 0.3 GRADUATION LINE. TWO OF THE IMAGES IDENTIFY THE CONDITIONS DESCRIBED ABOVE. THE CONDITIONS OBSERVED ARE ACCEPTABLE PER PRODUCT SPECIFICATION. THE TWO OTHER SAMPLES EACH HAD A MINOR SCRATCH CAUSING MISSING PRINT ON A CHARACTER GREATER THAN 50%: ONE ON THE 0.6 AND 0.7 GRADUATION LINES AND ANOTHER ON THE 0.7 GRADUATION LINE. BOTH OTHER PHOTOS IDENTIFY THE CONDITIONS AS DESCRIBED ABOVE. THE CONDITIONS OBSERVED ARE NON-CONFORMING PER PRODUCT SPECIFICATION. PRODUCTION RECORDS, AND PRODUCTION DATABASES WERE REVIEWED AS PART OF THIS INVESTIGATION. THIS IS THE FIRST COMPLAINT RELATED TO MISSING PRINT FOR BATCH 9112911 MANUFACTURED OVER THREE YEARS AGO. BATCH 9112911 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD LUER-LOK¿ SYRINGE EXPERIENCED SCALE MARKING PERMANENCY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON 13FEB2023, DURING AN UNRELATED PRODUCT COMPLAINT INVESTIGATION, A RETAINS EXAM AND COMPONENT EXAMINATION WAS PERFORMED ... FAINT PAINT WAS OBSERVED IN THE MEASUREMENTS OF 4 SYRINGES, WITHIN 4 DIFFERENT KITS (SYRINGE LOT: 8277864; SYRINGE CATALOG NUMBER: 309628). THERE WAS A TOTAL OF 120 RETAIN SAMPLES INSPECTED WITH FOUR KITS AFFECTED BY THIS DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD LUER-LOK¿ SYRINGE EXPERIENCED SCALE MARKING PERMANENCY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2023, DURING AN UNRELATED PRODUCT COMPLAINT INVESTIGATION, A RETAINS EXAM AND COMPONENT EXAMINATION WAS PERFORMED.FAINT PAINT WAS OBSERVED IN THE MEASUREMENTS OF 4 SYRINGES, WITHIN 4 DIFFERENT KITS (SYRINGE LOT: 8277864; SYRINGE CATALOG NUMBER: 309628). THERE WAS A TOTAL OF 120 RETAIN SAMPLES INSPECTED WITH FOUR KITS AFFECTED BY THIS DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349957 BD LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8277864 00382903096282

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown