BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ DISPOSABLE SYRINGE

    MDR report key: 7407289 · Received April 9, 2018

    Report

    Report Number
    1213809-2018-00196
    Event Type
    Malfunction
    Date Received
    April 9, 2018
    Date of Event
    February 5, 2018
    Report Date
    May 23, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. DHR REVIEW FOR BATCH 7082993 (P/N 309628): MANUFACTURING DATES: 03/28/2017 TO 04/05/2017. BATCH QUANTITY WAS 302,400. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7082993 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. THE REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. HOWEVER, A THOROUGH EVALUATION OF THE MOLDING, MARKING, ASSEMBLY AND PACKAGING PROCESSES WAS CONDUCTED. IT REVEALED NO POTENTIAL SOURCES OF PINK OR OTHER POLYESTER FIBER AS REPORTED IN THE REGENERON QC RESULTS MEMO TO BD. THEREFORE, BASED ON THE INVESTIGATION COMPLETED AND THE INFORMATION AVAILABLE TODAY THE SOURCE OF THE REPORTED FOREIGN MATTER COULD NOT AT THIS TIME BE ATTRIBUTED TO THE BD MANUFACTURING PROCESS. CAPA NOT REQUIRED AS NO DEFECTS WERE CONFIRMED. 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 · 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 AFTER DRAWING UP MEDICATION WITH A FILTER NEEDLE, FOREIGN MATTER (DESCRIBED AS A ¿PINK FUZZY¿) WAS FOUND FLOATING INSIDE THE MEDICATION IN A BD LUER-LOK¿ DISPOSABLE SYRINGE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249365 BD LUER-LOK¿ DISPOSABLE SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7082993 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other