BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 11668504 · Received April 14, 2021

    Report

    Report Number
    3003152976-2021-00197
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    December 21, 2020
    Report Date
    May 27, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUATION? YES. D10: RETURNED TO MANUFACTURER ON: 2021-05-24. CORRECTION THE MDRS H.10 HAS TYPO FOR LOT# 2006233 SAYS 200623 CORRECTION SHOULD BE 2006233 D.4. MEDICAL DEVICE LOT #: 2006233 D.4. MEDICAL DEVICE EXPIRATION DATE: 2025-05-31 H.4. DEVICE MANUFACTURE DATE: 2020-06-16 H6: INVESTIGATION SUMMARY A TOTAL OF SEVEN PHYSICAL SAMPLES DISPLAYING DIFFERENT DEFECTS, WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, ONE OF THE SAMPLES FROM LOT 2006233 WAS OBSERVED TO HAVE THE STOPPER IMPROPERLY ASSEMBLED, PARTIALLY DETACHED FROM THE PLUNGER ROD. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2006233, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. THE ASSEMBLY MACHINE HAS A VISION SYSTEM TO DETECT FOR MISSING OR IMPROPERLY ASSEMBLED STOPPERS. A TOTAL OF SEVEN PHYSICAL SAMPLES DISPLAYING DIFFERENT DEFECTS, WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. ALL PRODUCT WAS VISUALLY INSPECTED, A LEAKAGE PAST THE STOPPER WAS OBSERVED IN THE TWO SAMPLES OF LOT 2007029. THE PRODUCT WAS DISASSEMBLED FOR FURTHER EVALUATION, THERE WAS NO DAMAGE OR MOLDING DEFECTS FOUND IN THE PLUNGER ROD OR OTHER COMPONENTS THAT COULD HAVE CONTRIBUTED TO THE LEAKAGE OBSERVED AND THE STOPPER WAS VERIFIED TO BE PROPERLY ASSEMBLED ONTO THE PLUNGER ROD.. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2007029 , NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. THERE WERE NO INCIDENTS DOCUMENTED RELATED TO ANY FAILURES WITH THE DETECTION SYSTEM, THEREFORE WE CANNOT IDENTIFY WHY THE IMPACTED SAMPLE WAS NOT DISCARDED. BASED ON OUR INVESTIGATION, IT WAS DETERMINED THIS INCIDENT OCCURRED AS A RESULT OF IMPROPER ALIGNMENT OF THE PLUNGER/STOPPER DURING ASSEMBLY, THE IMPACTED UNIT NOT BEING PROPERLY DISCARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE EXPERIENCED A CASE OF LEAKAGE, AND A CASE OF DAMAGED/DEFORMED STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TODAY I HAVE MORE COMPLAINTS REGARDING BD 50 ML SYRINGES. THIS TIME IT IS NOT ONLY ABOUT THE ¿CLASSIC¿ ISSUE WITH THE STOPPER. DURING THE PRODUCTION WE NOTICED A SYRINGE THAT HAD AN ALREADY DEFORMED STOPPER. WE ALSO DISCOVERED SYRINGES WITH A BROKEN PLUNGER. ALL SYRINGES WERE USED IN THE PREPARATION OF CYTOSTATICS AND ARE CONTAMINATED EXTERNALLY.

    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 #: 2007029. MEDICAL DEVICE EXPIRATION DATE: 2025-06-30. DEVICE MANUFACTURE DATE: 2020-07-02. MEDICAL DEVICE LOT #: 200623. MEDICAL DEVICE EXPIRATION DATE: 2025-05-31. DEVICE MANUFACTURE DATE: 2020-06-16. INITIAL REPORTER PHONE #: (B)(4). 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 BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE EXPERIENCED A CASE OF LEAKAGE, AND A CASE OF DAMAGED/DEFORMED STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TODAY I HAVE MORE COMPLAINTS REGARDING BD 50 ML SYRINGES. THIS TIME IT IS NOT ONLY ABOUT THE ¿CLASSIC¿ ISSUE WITH THE STOPPER. DURING THE PRODUCTION WE NOTICED A SYRINGE THAT HAD AN ALREADY DEFORMED STOPPER. WE ALSO DISCOVERED SYRINGES WITH A BROKEN PLUNGER. ALL SYRINGES WERE USED IN THE PREPARATION OF CYTOSTATICS AND ARE CONTAMINATED EXTERNALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562602 BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1