BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 7542221 · Received May 24, 2018

    Report

    Report Number
    1213809-2018-00305
    Event Type
    Malfunction
    Date Received
    May 24, 2018
    Date of Event
    May 7, 2018
    Report Date
    June 4, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SAMPLE EVALUATION: A BIOHAZARD BAG WITH A HOLE CONTAINED TWO OPENED 3ML LUER-LOK PACKAGE AND A SINGLE LOOSE 3ML SYRINGE WAS RECEIVED, CONFIRMED TO BE FROM BATCH # 8042757 (P/N 309657). THE SAMPLE WAS VISUALLY EVALUATED. THE SAMPLE WAS FOUND TO HAVE A CAP AT THE LUER-LOK, THE CAP WAS NOT MANUFACTURED AT BD, CANAAN. THE PLUNGER WAS DRAWN TO 1-1/2 ML LINE. THE SAMPLE CONTAINED UNIDENTIFIED BLACK/DARK GREEN FLUID INSIDE THE SYRINGE AND INSIDE THE CAP. SOME LOOSE UNIDENTIFIED BLACK FOREIGN MATTER WAS ALSO FOUND INSIDE THE BARREL AT BARREL FLANGE OUTSIDE OF FLUID PATH, THE SIZE OF THE FOREIGN MATTER WAS GREATER THAN LEVEL 3. THE PRODUCT HAD BEEN MANIPULATED AFTER IT LEFT THE PLANT AS THE PRODUCT WAS NOT IN A SEALED PACKAGE AND NO FILLING AND NO CAPPING PROCESS IS PERFORMED DURING MANUFACTURING. PRODUCT DEFECT COULD NOT BE ATTRIBUTED TO THE MANUFACTURING PROCESS BASED ON THE SAMPLE RECEIVED. DHR REVIEW FOR BATCH 8042757 (P/N 309657): MANUFACTURING DATES: 03/03/2018 TO 03/05/2018. BATCH QUANTITY WAS 768,000. 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 8042757 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. INVESTIGATION CONCLUSION: PRODUCT DEFECT COULD NOT BE ATTRIBUTED TO THE MANUFACTURING PROCESS BASED ON THE SAMPLE RECEIVED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 FOREIGN MATTER (DESCRIBED AS ¿MIGHT BE MOLD¿) WAS FOUND IN A BD LUER-LOK¿ SYRINGE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385437 BD LUER-LOK¿ SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8042757 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other