BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ DISPOSABLE SYRINGE

    MDR report key: 7452358 · Received April 23, 2018

    Report

    Report Number
    1213809-2018-00231
    Event Type
    Malfunction
    Date Received
    April 23, 2018
    Date of Event
    March 30, 2018
    Report Date
    May 3, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096282
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SAMPLE EVALUATION: ONE LOOSE 1ML ASSEMBLED SYRINGE WAS RECEIVED AND REPORTED TO BE FROM BATCH # 7240885 (P/N 309628). MOLD C-08, CAVITY 25. THE SAMPLE WAS VISUALLY EVALUATED. BROWN FM WAS FOUND EMBEDDED IN THE BARREL WALL NEAR THE FLANGE. THE FM IS MOST LIKELY DEGRADED PLASTIC. THIS TYPE OF DEFECT IS COSMETIC AND DOES NOT POSE RISK TO THE CUSTOMER. HOWEVER, IT IS GREATER THAN LEVEL 3 IN SIZE, WHICH IS A REJECTABLE CONDITION PER PRODUCT SPECIFICATION. THE SYRINGE WAS ALSO FOUND TO HAVE MISSING PRINT BETWEEN 0.1 AND 0.5ML SCALE MARKINGS. THE PRINT IN THIS AREA WAS FAINT, LIKELY A RESULT OF THE SAMPLE HANDLING AND IS THEREFORE NOT CONSIDERED A DEFECT. DHR REVIEW FOR BATCH 7240885 (P/N 309628): MANUFACTURING DATES: 09/11/2017 TO 09/12/2017. BATCH QUANTITY WAS 302,400. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7240885 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT INVESTIGATION CONCLUSION: FM IS CONFIRMED BASED ON THE SAMPLE RECEIVED. THE FM IS MOST LIKELY DEGRADED PLASTIC. THIS TYPE OF DEFECT IS COSMETIC AND DOES NOT POSE RISK TO THE CUSTOMER. HOWEVER, IT IS GREATER THAN LEVEL 3 IN SIZE, WHICH IS A REJECTABLE CONDITION PER PRODUCT SPECIFICATION.

    Additional Manufacturer Narrative · 1

    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 BD LUER-LOK¿ DISPOSABLE SYRINGE HAD VISIBLE FOREIGN MATTER INSIDE THE BARREL. FOUND BEFORE USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292757 BD LUER-LOK¿ DISPOSABLE SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7240885 00382903096282

    Patients

    Seq Age Sex Outcome Treatment
    1 Other