BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD® SYRINGE 1 ML S/T BULK NON-STERILE

    MDR report key: 17741386 · Received September 13, 2023

    Report

    Report Number
    1213809-2023-01007
    Event Type
    Malfunction
    Date Received
    September 13, 2023
    Date of Event
    August 25, 2023
    Report Date
    January 20, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980580
    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

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED THE PAD PRINTING IS MISSING AND THE PLUNGER IS BENT. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, TWO PHOTOS OF 1ML LUER-SLIP SYRINGES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. ONE PHOTO SHOWS THREE LOOSE SYRINGES. TWO OF THE SYRINGES HAVE MISSING SCALE MARKINGS. ONE IS MISSING ALL OF THE MARKINGS AND THE OTHER HAD FAINT MARKINGS WITH MORE THAN 50% OF THE MARKINGS MISSING. ONE SYRINGE HAS THE PLUNGER ROD PULLED OUT AND IT APPEARS BENT. THE SECOND PHOTO SHOWS TWELVE LOOSE SYRINGES ON A TABLE NEXT TO A BAG OF LOOSE SYRINGES. NO DEFECTS CAN BE OBSERVED IN THE BAG OF SYRINGES, BUT ELEVEN OF THE SYRINGES OUT OF THE BAG ARE MISSING THE SCALE MARKINGS. NINE ARE MISSING MORE THAN 50% OF THE SCALE MARKINGS. ONE SYRINGE HAS THE PLUNGER ROD PULLED OUT AND APPEARS BENT. THE CONDITIONS OBSERVED ARE NON-CONFORMING PER PRODUCT SPECIFICATION. THE SCALE MARKING MISSING DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. THE BENT PLUNGER ROD DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER (B)(4) LOT 2272339. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 2272339 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN, SUBSEQUENTLY APPROVED FOR SHIPMENT, AND IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. THE OBSERVED DEFECTS APPEAR TO BE OCCURRING AT OR BELOW THEIR EXPECTED FREQUENCY; THEREFORE, NO CORRECT ACTIONS ARE REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    H3. 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

    ADDITIONAL INFORMATION RECEIVED MATERIAL#: (B)(4) BATCH#: 2272339 IT WAS REPORTED BY THE CUSTOMER THAT THE PAD PRINTING IS MISSING AND/OR BENT PLUNGER. VERBATIM: OUR CUSTOMER IS REPORTING PAD PRINTING MISSING AND/OR BENT PLUNGER (SEE PICTURES). THESE ISSUES ARE BEING REPORTED FOR XXX LOT NUMBER(S) LISTED BELOW. LOT 210187¿ VENDOR LOT 2272339 WE ARE CURRENTLY CHECKING OUR STOCK OF ~28,000 PIECES REMAINING. __________________________________________________________ TO ADD TO MY REQUEST BELOW, WE NOTE THAT THIS IS THE TIME THAT WE HAVE REQUESTED AN INVESTIGATION FOR THIS SAME PART. IN OUR PREVIOUS INVESTIGATION (REFERENCE NUMBER: (B)(4)) YOUR REPORT NOTED THAT ¿THE DEFECT WAS DISCOVERED DURING THE PRINTING PROCESS AND PROCESS ADJUSTMENTS WERE MADE TO CORRECT THE ISSUE¿. COULD YOU PLEASE PROVIDE DETAILS ON WHAT ¿PROCESS ADJUSTMENTS¿ HAVE BEEN MADE? RESPONSE RECEIVED ON 06-SEP-2023. FOR OUR (B)(4) ¿ THIS CASE CAN BE CLOSED ON YOUR SIDE AS THIS IS NO LONGER NEEDED. FOR OUR SECOND, SEPARATE ISSUE, OUR (B)(4). THE ORIGINAL EMAILS ARE BELOW, AND ANSWERS TO CASE QUESTIONS ARE BELOW. ¿ WHAT IS THE TOTAL QUANTITY OF AFFECTED PRODUCT? 29 PIECES ¿ WAS THERE ANY PATIENT INVOLVEMENT? NO ¿ IF YES, WAS THERE ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED? N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THAT 28 OF THE BD® SYRINGE 1 ML S/T BULK NON-STERILE HAD BENT PLUNGERS. REPORT 2 OF 2. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: OUR CUSTOMER IS REPORTING PAD PRINTING MISSING AND/OR BENT PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2220788 BD® SYRINGE 1 ML S/T BULK NON-STERILE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2272339

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown