BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGE

    MDR report key: 7035553 · Received November 15, 2017

    Report

    Report Number
    1213809-2017-00266
    Event Type
    Malfunction
    Date Received
    November 15, 2017
    Date of Event
    October 23, 2017
    Report Date
    January 23, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS: DHR REVIEW FOR BATCH 7170620 (P/N 301027): MANUFACTURING DATES: 06/22/2017 ¿ 06/23/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7170620 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. SAMPLE EVALUATION: TEN LOOSE 5ML SYRINGES WERE RECEIVED BY BD (B)(4) AND REPORTED TO BE FROM BATCH # 7170620 (P/N 301027). THE SAMPLES WERE VISUALLY EVALUATED. EACH OF THE TEN SYRINGES HAD PRINT ISSUES ON THE SYRINGE BARREL BETWEEN THE 1ML GRAD LINE AND THE BARREL COLLAR. 5 OF THE SAMPLES HAD MISSING PRINT, WITH MORE THAN 50% OF AT LEAST ONE ITEM MISSING. 5 OF THE SAMPLES HAD INK SMEARS AROUND THE 0ML GRAD LINE. ALL OF THE OBSERVED PRINT DEFECTS WERE CONSIDERED REJECTABLE. THE PRINT ISSUES OBSERVED APPEARED TO BE DUE TO AN INTERRUPTION IN INK FLOW. HOWEVER, ROOT CAUSE FOR THE INTERRUPTION COULD NOT BE DETERMINED. BASED ON THE SAMPLE EVALUATION: ¿ CONFIRMED: BD (B)(4) WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. CONCLUSION: THE PRINT ISSUES OBSERVED APPEARED TO BE DUE TO AN INTERRUPTION IN INK FLOW. HOWEVER, ROOT CAUSE FOR THE INTERRUPTION COULD NOT BE DETERMINED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCALE MARKINGS ON A BD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGE WERE ILLEGIBLE. THIS WAS NOTICED BEFORE USE AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814762 BD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7170620

    Patients

    Seq Age Sex Outcome Treatment
    1 Other