BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 7266867 · Received February 13, 2018

    Report

    Report Number
    9610847-2018-00014
    Event Type
    Malfunction
    Date Received
    February 13, 2018
    Date of Event
    January 19, 2018
    Report Date
    April 11, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903096801
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: MANUFACTURING INVESTIGATION: THE CUSTOMER RETURNED REPRESENTATIVE SAMPLES TO THE BD COMPLAINTS CUSTOMER SERVICE TEAM: FIVE CONVENIENCE TRAYS (20 SYRINGES/EA) OF CAT# 309680, LOTS 7184872, 7242754, 7214744, 7270964, 7184875 (ONE TRAY FROM EACH). ALL RETURNED SAMPLES WERE SENT TO THE BD SYRINGE MANUFACTURING SITE FOR EVALUATION. ALL SAMPLES WERE VISUALLY EVALUATED AND NO ANOMALIES WERE OBSERVED. THE MANUFACTURING SITE ALSO CONDUCTED A REVIEW OF THE BATCH RECORDS (I.E., DHR) FOR ALL SEVEN (7) TRAY LOTS REPORTED. NO UNUSUAL OBSERVATIONS WERE FOUND DURING MANUFACTURING OF THE REPORTED LOTS. THERE WERE NO QUALITY NOTIFICATIONS RELATED TO THE ISSUES REPORTED. THE BATCH REVIEWS ALSO SHOWED THERE WERE NO FAILURES FOUND DURING DIMENSIONAL MEASUREMENTS ON MOLDED SYRINGE COMPONENTS AND DURING LEAKAGE PAST STOPPER TESTING PERFORMED ON SYRINGES DURING FIRST PIECE INSPECTIONS (FPI). COMPLAINTS ANALYSIS: A HISTORICAL COMPLAINT INQUIRY FOR THE SAME LEAKAGE-RELATED ISSUE WAS PERFORMED. NO OTHER COMPLAINTS WERE REPORTED FOR ANY OF THE 7 TRAY LOTS INVOLVED. THIS CONFIRMED ONLY THE ABOVE REFERENCED COMPLAINTS AND ASSOCIATED INVOLVED LOTS HAVE BEEN REPORTED, ALL LOCALIZED AT THE (B)(6) REGION ONLY. BASED ON THE ABOVE INVESTIGATION, THE RECORDS INDICATES THAT THE 7 TRAY LOTS WERE ALL MANUFACTURED PER ESTABLISHED PROCEDURES AND MET THE ACCEPTANCE CRITERIA BEFORE RELEASING FOR DISTRIBUTION. THE PRACTICE OF STORING MEDICATION WITHIN THE SYRINGE BY THE CUSTOMER IS CONSIDERED AN OFF-LABEL USE. IN ADDITION, ENVIRONMENTAL CONDITIONS DURING SHIPPING OUTSIDE OF BD'S CONTROL MAY HAVE HAD AN UNKNOWN IMPACT ON THE SYRINGES. BOTH FACTORS MAY HAVE CONTRIBUTED TO THE LEAKAGE CONDITION. BD DOES NOT BELIEVE THAT THE MANUFACTURING PROCESS IS RELATED TO THE REPORTED LEAKAGE ISSUES. NO CORRECTIVE ACTION IS REQUIRED. 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 · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. NO LOT # PROVIDED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 SEVERAL BD¿ PHARMACY CONVENIENCE TRAY LUER-LOK¿ STERILE SYRINGE(S) LEAKED DURING USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111760 BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY CONVENTIONAL SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN 30382903096801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other