BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE ONLY SLIP TIP, NON-STERILE, BULK

    MDR report key: 7531686 · Received May 22, 2018

    Report

    Report Number
    1213809-2018-00295
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    May 3, 2018
    Report Date
    July 9, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A TOTAL OF 44 LOOSE 10ML S/T SYRINGES WAS RECEIVED, REPORTED TO BE FROM BATCH #7111555 (P/N 301030). THE SAMPLES WERE VISUALLY EVALUATED. THE 44 SYRINGES WERE FOUND TO HAVE NO STOPPER ON THE PLUNGER ROD. DHR REVIEW FOR BATCH 7111555 (P/N 301030): MANUFACTURING DATES: 05/20/2017 TO 05/22/2017. BATCH QUANTITY WAS (B)(4). ASSEMBLY RECORDS WERE REVIEWED AS PART OF THIS DHR REVIEW. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT. NO QUALITY NOTIFICATION WERE ISSUED RELATED TO THE COMPLAINT DEFECT. NO STOPPERS ON PLUNGERS WERE DETECTED DURING THE MANUFACTURE OF THIS BATCH. ADJUSTMENTS WERE MADE BEFORE PRODUCTION RESUMED. BATCH 7111555 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. MACHINE LOGS INDICATE AN ISSUE WITH STOPPER VIBRATORY FEEDER SYSTEM. THE ISSUE WAS CORRECTED BY IDENTIFYING AND REPLACING THE MALFUNCTIONING PART. POSSIBLE ROOT CAUSE, THE MISSING STOPPER DEFECT IS LIKELY DUE TO VIBRATORY FEEDER ISSUE DURING THE ASSEMBLY PROCESS. AS CORRECTIVE ACTION, THE DEFECTIVE PART WAS REPLACED WHEN THE ISSUE WAS OBSERVED DURING PRODUCTION. (B)(4), WHICH IS WELL WITHIN THE QUALITY LIMITS. NO ADDITIONAL ACTIONS ARE REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    CORRECTION: DATE RECEIVED BY MANUFACTURER: 05/04/2018.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED BD¿ SLIP-TIP SYRINGE(S) WITH MISSING PLUNGERS AND TOPS. THE SYRINGES WERE NOT USED AND THERE WAS NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTIONS.

    Additional Manufacturer Narrative · 1

    (B)(6). A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED BD¿ SLIP-TIP SYRINGE(S) WITH MISSING PLUNGERS AND TOPS. THE SYRINGES WERE NOT USED AND THERE WAS NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378160 BD¿ SYRINGE ONLY SLIP TIP, NON-STERILE, BULK SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7111555

    Patients

    Seq Age Sex Outcome Treatment
    1 Other