BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 8206619 · Received December 31, 2018

    Report

    Report Number
    1213809-2018-01002
    Event Type
    Malfunction
    Date Received
    December 31, 2018
    Date of Event
    December 11, 2018
    Report Date
    January 22, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT MULTIPLE BD SYRINGE LUER-LOK¿ TIPS FROM TWO LOT NUMBERS WERE FOUND TO HAVE PARTICULATE MATTER CONTAMINATION, DAMAGE, EXCESS LUBRICANT, INCLUSIONS, AND SCALE MARKING ISSUES PRIOR TO USE. LOT NUMBER 7121638 REPORTED 5 OCCURRENCES OF PARTICULATE MATTER CONTAMINATION, 32 OCCURRENCES OF DAMAGE, 32 OCCURRENCES OF EXCESS LUBRICANT, 5 OCCURRENCES OF INCLUSIONS, AND 239 OCCURRENCES OF SCALE MARKING ISSUES. LOT NUMBER 7215975 REPORTED 6 OCCURRENCES OF PARTICULATE MATTER CONTAMINATION, 8 OCCURRENCES OF INCLUSIONS, AND 52 OCCURRENCES OF SCALE MARKING ISSUES. THE DATE/TIME AND OR PATIENT INFORMATION FOR THESE OCCURRENCES IS UNKNOWN. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE TWO PROVIDED LOT NUMBER(S) THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. ROOT CAUSE DESCRIPTION: NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. RATIONALE: 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MULTIPLE BD SYRINGE LUER-LOK¿ TIPS FROM TWO LOT NUMBERS WERE FOUND TO HAVE PARTICULATE MATTER CONTAMINATION, DAMAGE, EXCESS LUBRICANT, INCLUSIONS, AND SCALE MARKING ISSUES PRIOR TO USE. LOT NUMBER 7121638 REPORTED 5 OCCURRENCES OF PARTICULATE MATTER CONTAMINATION, 32 OCCURRENCES OF DAMAGE, 32 OCCURRENCES OF EXCESS LUBRICANT, 5 OCCURRENCES OF INCLUSIONS, AND 239 OCCURRENCES OF SCALE MARKING ISSUES. LOT NUMBER 7215975 REPORTED 6 OCCURRENCES OF PARTICULATE MATTER CONTAMINATION, 8 OCCURRENCES OF INCLUSIONS, AND 52 OCCURRENCES OF SCALE MARKING ISSUES. THE DATE/TIME AND OR PATIENT INFORMATION FOR THESE OCCURRENCES IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6) A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7121638. MEDICAL DEVICE EXPIRATION DATE: 04/30/2022. DEVICE MANUFACTURE DATE: 05/01/2017. MEDICAL DEVICE LOT #: 7215975. MEDICAL DEVICE EXPIRATION DATE: 07/31/2022. DEVICE MANUFACTURE DATE: 08/03/2017.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE BD SYRINGE LUER-LOK¿ TIPS WERE FOUND TO HAVE PARTICULATE MATTER CONTAMINATION, DAMAGE, EXCESS LUBRICANT, INCLUSIONS, AND SCALE MARKING ISSUES PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045790 BD SYRINGE LUER-LOK¿ TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other