BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿

    MDR report key: 6905055 · Received September 29, 2017

    Report

    Report Number
    1213809-2017-00146
    Event Type
    Malfunction
    Date Received
    September 29, 2017
    Date of Event
    September 5, 2017
    Report Date
    December 10, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: DHR/QN REVIEW FOR BATCH 7031978 (P/N 309658): MANUFACTURING DATES: 2/18/2017 ¿ 2/19/2017. BATCH SIZE WAS (B)(4) PIECES. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. THERE WAS A RECORDED INSTANCE OF ISSUES WITH THE MARKER THAT CAUSED INK RINGS. BATCH 7031978 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. SAMPLE EVALUATION: FIVE SEALED 3ML PACKAGED SYRINGES WERE RECEIVED BY BD (B)(4) AND CONFIRMED TO BE FROM BATCH #7031978 (P/N 309658). THE SAMPLES WERE VISUALLY EVALUATED. ALL FIVE SYRINGES HAD PRINT ISSUES THAT INCLUDED MISSING THE SCALE MARKINGS AND HAVING INK RINGS OF VARYING INTENSITY IN PLACE OF THE SCALE. BASED ON SAMPLE, THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. 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. ROOT CAUSE DESCRIPTION: N/A FOR LEVEL A INVESTIGATION. RATIONALE: BASED ON THE SEVERITY ASSIGNED TO THIS COMPLAINT AND THE RESULTS OF THE COMPLAINT LOT HISTORY CHECK, CAPA IS NOT REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE SCALE MARKINGS ON THE BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿ WERE BLURRED OR NON-EXISTENT MAKING THE PRODUCT UNUSABLE. FOUND BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684289 BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿ SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7031978

    Patients

    Seq Age Sex Outcome Treatment
    1 Other