BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 9354539 · Received November 21, 2019

    Report

    Report Number
    3003152976-2019-00785
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    November 7, 2019
    Report Date
    December 4, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE SAMPLE, A LEAK WAS OBSERVED BETWEEN THE STOPPER RIBS. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOTS 1905234 AND 1907257, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 1905234 AND AN ADDITIONAL TEN SAMPLES OF LOT 1907257 WERE USED TO CONDUCT A LEAKAGE TEST. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS NOTED, AND NO LEAK WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CYTOTOXIC LEAKAGE OCCURRED PAST THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE STOPPER DURING USE. LOT #'S 1905234 AND 1907257 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "ANOTHER EXAMPLE OF CONTAMINATION ILLUSTRATED TODAY WITH CYTOTOXICS. PHOTO PROVIDED DISPLAYS LEAKAGE PAST STOPPER."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1905234. MEDICAL DEVICE EXPIRATION DATE: 2024-04-30. DEVICE MANUFACTURE DATE: 2019-05-16. MEDICAL DEVICE LOT #: 1907257. MEDICAL DEVICE EXPIRATION DATE: 2024-06-30. DEVICE MANUFACTURE DATE: 2019-07-31. 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 CYTOTOXIC LEAKAGE OCCURRED PAST THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE STOPPER DURING USE. LOT #'S 1905234 AND 1907257 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "ANOTHER EXAMPLE OF CONTAMINATION ILLUSTRATED TODAY WITH CYTOTOXICS. PHOTO PROVIDED DISPLAYS LEAKAGE PAST STOPPER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154336 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMI BECTON DICKINSON, S.A. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other