BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 11355391 · Received February 19, 2021

    Report

    Report Number
    3003152976-2021-00099
    Event Type
    Malfunction
    Date Received
    February 19, 2021
    Date of Event
    January 26, 2021
    Report Date
    April 6, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-02-16. H6: INVESTIGATION SUMMARY: TWO USED SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED AND A LEAKAGE PAST THE STOPPER RIBS WAS OBSERVED. THERE ARE NO DEFECTS OR DAMAGE WAS NOTED ON ANY OF THE SAMPLES OR COMPONENTS AND THE STOPPERS WERE VERIFIED TO BE PROPERLY ASSEMBLED ONTO THE PLUNGER ROD. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOTS 2010015 AND 2002297, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES, INCLUDING LEAKAGE TESTING AND TIGHTNESS TESTING TO VERIFY THE SEAL OF THE STOPPER. THE RETURNED SAMPLES UNDERWENT THESE TESTS AND IN ALL CASES THE PRODUCT MET REQUIRED SPECIFICATION. GIVEN THAT NO DEFECTS WERE OBSERVED IN EITHER SAMPLE AND BOTH PRODUCT MET REQUIRED LIMITS DURING LEAKAGE TESTING, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGES EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THESE ARE THE BATCHES 2010015 AND 2002297. THE SYRINGES ARE USED, AMONG OTHER THINGS, TO RAISE CYTOSTATICS AND TO INJECT THEM INTO ANOTHER MEDIUM. SO IT'S IMPORTANT THAT THEY DON'T LEAK. IT MAY ALSO BE THAT MEDICATION IS RAISED IN THE SYRINGE AND DELIVERED TO THE DEPARTMENT. AGAIN, IT WOULD NOT BE DESIRABLE FOR THE SYRINGES TO LEAK. SINCE WE HAVE ALREADY EXPERIENCED THIS, WE WANT TO HEAR AS SOON AS POSSIBLE WHAT THE PROBLEM IS AND HOW THIS SITUATION WILL BE RESOLVED. THE CHARGES IN QUESTION HAVE BEEN QUARANTINED AS WE CANNOT ASSESS WHICH SYRINGE WILL AND WILL NOT LEAK.

    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 #: 2010015. MEDICAL DEVICE EXPIRATION DATE: 2025-09-30. DEVICE MANUFACTURE DATE: 2020-09-30. MEDICAL DEVICE LOT #: 2002297. MEDICAL DEVICE EXPIRATION DATE: 2025-01-31. DEVICE MANUFACTURE DATE: 2020-02-26. INITIAL REPORTER FIRST NAME: (B)(6). INITIAL REPORTER LAST NAME: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGES EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THESE ARE THE BATCHES 2010015 AND 2002297. THE SYRINGES ARE USED, AMONG OTHER THINGS, TO RAISE CYTOSTATICS AND TO INJECT THEM INTO ANOTHER MEDIUM. SO IT'S IMPORTANT THAT THEY DON'T LEAK. IT MAY ALSO BE THAT MEDICATION IS RAISED IN THE SYRINGE AND DELIVERED TO THE DEPARTMENT. AGAIN, IT WOULD NOT BE DESIRABLE FOR THE SYRINGES TO LEAK. SINCE WE HAVE ALREADY EXPERIENCED THIS, WE WANT TO HEAR AS SOON AS POSSIBLE WHAT THE PROBLEM IS AND HOW THIS SITUATION WILL BE RESOLVED. THE CHARGES IN QUESTION HAVE BEEN QUARANTINED AS WE CANNOT ASSESS WHICH SYRINGE WILL AND WILL NOT LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245471 BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 2002297

    Patients

    Seq Age Sex Outcome Treatment
    1