BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML LUER-LOK SYRINGE

    MDR report key: 9256704 · Received October 30, 2019

    Report

    Report Number
    3003152976-2019-00747
    Event Type
    Malfunction
    Date Received
    October 30, 2019
    Date of Event
    October 14, 2019
    Report Date
    December 13, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: MULTIPLE SAMPLES OF 50ML LL LOT 1902252 AND LOT 1902237 WERE RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR MOLDING DEFECT WAS IDENTIFIED ON ANY OF THE SAMPLES RETURNED. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY DOCUMENTED QUALITY ISSUES DURING THE PRODUCTION OF LOTS 1902252, 1902236 AND 1902237 THAT COULD HAVE CONTRIBUTED TO REPORTED INCIDENT. FIVE SAMPLES FROM LOT 1902252 AND LOT 1902237 WERE USED FOR ADDITIONAL EVALUATION, FILLING THE SYRINGES WITH WATER, NO BUBBLES, AIR, OR OTHER ANOMALY'S WERE OBSERVED DURING THIS PROCESS. FINAL PRODUCTS FOR THIS REFERENCE AND LOT SIZE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. BASED UPON THE VISUAL INSPECTION OF THE SAMPLES RECEIVED AND THE QUALITY TEAM'S INVESTIGATION, WE WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS INCIDENT. MANUFACTURING PERSONNEL HAVE BEEN MADE AWARE OF YOUR EXPERIENCE TO INCREASE AWARENESS OF THIS MATTER. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE HAD AIR IN IT. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WAS ASKED QUITE SOME TIME AGO TO REMOVE SYRINGE 50ML DUE TO A FAULT. SINCE THEN I HAVE BEEN TRYING TO ESTABLISH HOW I CAN RETURN THESE FOR EITHER CREDIT OR REPLACEMENT. WITHDRAWN AS SYRINGES HAVE BEEN FOUND WITH AIR IN THE SYRINGE AND/OR THE LINE DURING INFUSION DUE TO A PROBABLE MANUFACTURING FAULT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1902252. MEDICAL DEVICE EXPIRATION DATE: 2024-01-31. DEVICE MANUFACTURE DATE: 2019-02-04. MEDICAL DEVICE LOT #: 1902236. MEDICAL DEVICE EXPIRATION DATE: 2024-01-31. DEVICE MANUFACTURE DATE: 2019-02-25. MEDICAL DEVICE LOT #: 1902237. MEDICAL DEVICE EXPIRATION DATE: 2024-01-31. DEVICE MANUFACTURE DATE: 2019-02-26. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE HAD AIR IN IT. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WAS ASKED QUITE SOME TIME AGO TO REMOVE SYRINGE 50ML DUE TO A FAULT. SINCE THEN I HAVE BEEN TRYING TO ESTABLISH HOW I CAN RETURN THESE FOR EITHER CREDIT OR REPLACEMENT. WITHDRAWN AS SYRINGES HAVE BEEN FOUND WITH AIR IN THE SYRINGE AND/OR THE LINE DURING INFUSION DUE TO A PROBABLE MANUFACTURING FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052484 BD PLASTIPAK 50ML LUER-LOK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other