BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ LUER-LOK¿ SYRINGE

    MDR report key: 7475871 · Received May 1, 2018

    Report

    Report Number
    1213809-2018-00277
    Event Type
    Malfunction
    Date Received
    May 1, 2018
    Date of Event
    November 22, 2017
    Report Date
    August 17, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096467
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURER: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD PLASTIPAK LUER-LOK SYRINGE THERE WAS AN ISSUE WITH SCALE MARKING ERROR. IT WAS STATED ¿THERE WERE NO MARKINGS ON THE BARREL OF THE SYRINGE.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A SINGLE 5ML LUER-LOK SYRINGE IN AN OPENED PACKAGE WAS RECEIVED, CONFIRMED TO BE FROM BATCH # 6243931 (P/N 309646). THE SAMPLE WAS VISUALLY EVALUATED. THE SAMPLE WAS FOUND WITH NO SCALE MARKINGS ON THE SYRINGE. MINOR DAMAGE WAS ALSO OBSERVED ON THE BARREL WALL AND BARREL STEP NEAR FLANGE. MISSING PRINT IS A REJECTABLE CONDITION PER PRODUCT SPECIFICATION. DHR REVIEW FOR BATCH 6243931 (P/N 309646): MANUFACTURING DATES: 09/17/2016 TO 09/18/2016. BATCH QUANTITY WAS (B)(4). PRINTING AND ASSEMBLY RECORDS WERE REVIEWED AS PART OF THIS DHR REVIEW. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 6243931 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. PRODUCT DEFECT CONFIRMED BASED ON SAMPLE EVALUATION. IT IS POSSIBLE A BLANK BARREL IS DUE TO A LACK OF INK TRANSFER AT PRINTER START UP AND WAS INADVERTENTLY NOT DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE THERE WAS AN ISSUE WITH SCALE MARKING ERROR. IT WAS STATED ¿THERE WERE NO MARKINGS ON THE BARREL OF THE SYRINGE.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD PLASTIPAK LUER-LOK SYRINGE THERE WAS AN ISSUE WITH SCALE MARKING ERROR. IT WAS STATED ¿THERE WERE NO MARKINGS ON THE BARREL OF THE SYRINGE.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317830 BD PLASTIPAK¿ LUER-LOK¿ SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 6243931 30382903096467

    Patients

    Seq Age Sex Outcome Treatment
    1 Other