BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 ML BD LUER-LOK¿ DISPOSABLE SYRINGE

    MDR report key: 7059808 · Received November 27, 2017

    Report

    Report Number
    1213809-2017-00299
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 1, 2017
    Report Date
    January 31, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: DHR REVIEW FOR BATCH 6182965: MANUFACTURING DATES: 07/11/2016 TO 07/12/2016. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 6182965 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. SAMPLE EVALUATION: ONE LOOSE 1ML ASSEMBLED SYRINGE WAS RECEIVED BY BD (B)(4) AND REPORTED TO BE FROM BATCH # 6182965. THIS MATERIAL IS MANUFACTURED IN (B)(4) AS A SYRINGE ONLY PRODUCT WITHOUT A NEEDLE ATTACHED. THE SAMPLE WAS VISUALLY EVALUATED. THE SYRINGE HAD A NEEDLE ATTACHED. NO VISIBLE DEFECTS INCLUDING FOREIGN MATTER WERE OBSERVED. THE NEEDLE WAS REMOVED TO BETTER EVALUATE THE SYRINGE TIP. NO FM WAS OBSERVED UNDER THE NEEDLE ON THE BARREL TIP. THREE PHOTOS WERE RECEIVED FOR EVALUATION. IN THE PHOTOS, A NEEDLE WAS ATTACHED TO THE SYRINGE. THEN THE NEEDLE WAS REMOVED AND A THIN FIBER WAS OBSERVED ON THE TIP OF THE BARREL. THE FIBER WAS THEN REMOVED AND MEASURED TO BE APPROXIMATELY 1.0 CM. THE PRODUCT SUPPLIED BY BD (B)(4) IS A SYRINGE ONLY PRODUCT ¿ NO NEEDLE. THE FIBER OBSERVED IN THE PHOTOS WAS BETWEEN THE HUB AND THE BARREL TIP. THEREFORE IT IS POSSIBLE TO HAVE BEEN INTRODUCED AFTER THE NEEDLE WAS BEING ATTACHED TO THE SYRINGE. THE FM ORIGIN COULD NOT BE TRACED TO THE SYRINGE MANUFACTURING PROCESS AT THIS TIME. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. CONCLUSION: BASED ON THE SAMPLE EVALUATION: CONFIRMED: BD (B)(4) WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE, HOWEVER THE DEFECT COULD NOT BE CONFIRMED TO ORIGINATE AT THE MANUFACTURING PLANT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLACK FOREIGN MATTER WAS FOUND ON THE TIP OF THE BARREL OF A 1 ML BD LUER-LOK¿ DISPOSABLE SYRINGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840813 1 ML BD LUER-LOK¿ DISPOSABLE SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 6182965 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other