BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10CC S/T WOS STERILE WATER BNS

    MDR report key: 9985810 · Received April 22, 2020

    Report

    Report Number
    1213809-2020-00268
    Event Type
    Malfunction
    Date Received
    April 22, 2020
    Date of Event
    April 2, 2020
    Report Date
    May 18, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TEN LOOSE 10ML SYRINGES WERE RECEIVED AND VISUALLY EVALUATED. PART OF THE PRINT ON THE BARREL WAS OBSERVED TO BE MISSING. THE AFFECTED PORTION WERE THE WORDS ¿NOT FOR INJECTION¿ WITH THE BOTTOM PART OF THE WORD ¿NOT¿ MISSING AT AN ANGLE ON ALL TEN BARRELS WITH APPROXIMATELY HALF OF THE LETTERS MISSING. THE BOTTOM PART OF THE WORDS ¿FOR INJECTION¿ WERE SLIGHTLY AFFECTED ON ONLY A FEW OF THE BARRELS WHILE REMAINING LEGIBLE. THE AMOUNT OF MISSING PRINT OBSERVED WAS REJECTABLE PER PRODUCT SPECIFICATION. A POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKER SETUP. THE DEFECT LIKELY OCCURRED WHEN PAD ROLL AND/OR CYLINDER WERE BEING ADJUSTED. IT IS POSSIBLE DURING MARKER ADJUSTMENTS THE DEFECTIVE PRODUCT WAS NOT PROPERLY CONTAINED AND GOT MIXED WITH THE GOOD PRODUCT. THE DEFECTIVE QUANTITY IS LIKELY TO BE LIMITED AND ISOLATED. THE AQL FOR MISSING PRINT IS 0.25%. THE DEFECTIVE RATE IDENTIFIED IS 10 OUT OF 428,400, WHICH IS 0.0023%. THE REPORTED 500 DEFECTS COULD NOT BE CONFIRMED, HOWEVER DEFECTIVE RATE WOULD BE 500 OUT OF 428,400 WHICH IS 0.12% AND WITHIN THE AQL FOR THE BATCH. DHR WAS PERFORMED. A QN WAS ISSUED FOR PRINT ISSUES NOT DIRECTLY RELATED TO MISSING PRINT. MARKING PROCESS WAS ADJUSTED AND PRODUCT REQUALIFIED PER APPLICABLE AQL. BATCH 0022961 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 500 SYRINGES 10CC S/T WOS STERILE WATER BNS WERE FOUND WITH ILLEGIBLE SCALE MARKINGS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UNFORTUNATELY, DURING MANUFACTURING PROCESS PRODUCTION PERSONNEL DETECTED ILLEGIBLE PRINT IN THE PART NUMBER OF PN: FLX-30005."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: N/A. 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 · 1

    IT WAS REPORTED THAT 500 SYRINGES 10CC S/T WOS STERILE WATER BNS WERE FOUND WITH ILLEGIBLE SCALE MARKINGS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UNFORTUNATELY, DURING MANUFACTURING PROCESS PRODUCTION PERSONNEL DETECTED ILLEGIBLE PRINT IN THE PART NUMBER OF PN: FLX-30005."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452390 SYRINGE 10CC S/T WOS STERILE WATER BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 0022961

    Patients

    Seq Age Sex Outcome Treatment
    1 Other