BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 7686452 · Received July 13, 2018

    Report

    Report Number
    1213809-2018-00414
    Event Type
    Malfunction
    Date Received
    July 13, 2018
    Date of Event
    June 21, 2018
    Report Date
    August 14, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE PICTURE AND ONE LOOSE 3ML ASSEMBLED SYRINGE WAS RECEIVED AND REPORTED TO BE FROM BATCH# 8001759 OR 7338763 (P/N 301073). THE SAMPLE WAS VISUALLY EVALUATED. THE SYRINGE WAS FOUND TO HAVE EMBEDDED FOREIGN MATTER INSIDE THE WALL OR THE COLLAR. THE FOREIGN MATTER OBSERVED IS LIGHT BROWN IN COLOR AND LARGER THAN LEVEL 3 IN SIZE, THIS IS A REJECTABLE CONDITION PER PRODUCT SPECIFICATION. THE EMBEDDED FOREIGN MATTER IS MOST LIKELY DEGRADED PLASTIC FROM THE MOLDING PROCESS. THIS OCCURS WHEN THE RESIN IS EXPOSED TO PROLONGED HIGH TEMPERATURES INSIDE THE MOLDING PRESS, SUCH AS DURING START UP. THE DEFECT RATE FOR EACH BATCH # SUPPLIED ARE WITHIN THE ACCEPTANCE CRITERIA, NO CORRECTIVE ACTIONS RECOMMENDED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THIS IS THE 2ND RELATED COMPLAINT FOR FM ON THE POSSIBLE LOT NUMBERS 8001759. RELATED COMPLAINT: (B)(4). OCCURRENCE IS 2. THE SEVERITY LEVEL IS S1. THE INVESTIGATION LEVEL IS B. THIS IS THE 2ND RELATED COMPLAINT FOR FM ON THE POSSIBLE LOT NUMBERS 7338763. RELATED COMPLAINT: (B)(4). OCCURRENCE IS 2. THE SEVERITY LEVEL IS S1. THE INVESTIGATION LEVEL IS B. RELEASE DATE: 01/05/2018. RELEASED QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 8001759 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. 7338763 RELEASE DATE: 12/16/2017. RELEASED QUANTITY WAS 960,000. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7338763 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. THE AQL FOR FOREIGN MATTER EMBEDDED ON COMPONENT IS 0.65%.THE DEFECT RATE FOR EACH BATCH # SUPPLIED ARE WITHIN THE ACCEPTANCE CRITERIA. NO CORRECTIVE ACTIONS RECOMMENDED. (B)(4). ADDITIONALLY, EMBEDDED FM DEFECTS/IMPERFECTIONS ARE SAFE AND ACCEPTABLE FOR THEIR INTENDED CLINICAL APPLICATIONS. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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 · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURER: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE HAD BIG IMPURITIES FOREIGN MATTER IN THE SYRINGE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE HAD BIG IMPURITIES FOREIGN MATTER IN THE SYRINGE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE POTENTIAL LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH POTENTIAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8001759, EXPIRATION DATE: 12/31/2022, MANUFACTURE DATE: 01/01/2018. MEDICAL DEVICE LOT #: 7338763, EXPIRATION DATE: 11/30/2022, MANUFACTURE DATE: 12/04/2017. 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 HAD BIG IMPURITIES FOREIGN MATTER IN THE SYRINGE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528304 BD LUER-LOK¿ SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other