BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE

    MDR report key: 7342967 · Received March 15, 2018

    Report

    Report Number
    1213809-2018-00160
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    March 5, 2018
    Report Date
    April 4, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096466
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWO 5ML LUER LOK SYRINGES IN OPENED BLISTERPACKS WERE RECEIVED FOR INVESTIGATION CONFIRMED FROM LOT NUMBER #6212868, CATALOG # 309646. ONE SYRINGE WAS RETURNED WITH MEDICATION RESIDUE INSIDE BARREL AND ON PLUNGER ROD. BASED ON VISUAL EXAMINATION OF THE TWO RETURNED SAMPLES, CRACKED BARREL WAS OBSERVED ON BOTH SAMPLES; HOWEVER, ONE SYRINGE REVEALED A CRACK ALONG THE SYRINGE BARREL FROM GRADUATION MARK 2ML- 5ML. PRODUCT DEFECT CONFIRMED BASED ON SAMPLE EVALUATION PERFORMED. DHR REVIEW FOR BATCH 6212868 (P/N 309646): MANUFACTURING DATES: 08/13/2016 TO 08/14/2016. BATCH QUANTITY WAS (B)(4). 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 6212868 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT INVESTIGATION CONCLUSION: BASED ON THE SEVERITY AND OCCURRENCE A ROOT CAUSE IS NOT NECESSARY.

    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 BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE PRODUCT LEAKED FROM A CRACK ON THE SYRINGE WHEN DRAWING UP FLUID FOR USE. FOUND DURING USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185601 BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 6212868 00382903096466

    Patients

    Seq Age Sex Outcome Treatment
    1 Other