BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 11206231 · Received January 21, 2021

    Report

    Report Number
    3003152976-2021-00044
    Event Type
    Malfunction
    Date Received
    January 21, 2021
    Date of Event
    December 30, 2020
    Report Date
    March 3, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 1/27/2021. H.6. INVESTIGATION: TWO USED SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A LEAKAGE PAST THE STOPPER RIBS WAS OBSERVED. THERE WAS NO DAMAGE OR MOLDING DEFECTS NOTED IN THE PLUNGER ROD OR OTHER COMPONENTS THAT COULD HAVE CAUSED THE LEAK AND THE STOPPER WAS VERIFIED TO BE PROPERLY ASSEMBLED ONTO THE PLUNGER ROD. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 1910304 , NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 1910304 WERE USED TO CONDUCT A LEAKAGE TEST. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS NOTED, AND NO LEAK WAS IDENTIFIED. PRODUCT UNDERGOES VISUAL AND FUNCTIONAL INSPECTIONS THROUGHOUT MANUFACTURING, INCLUDING TIGHTNESS TESTING TO VERIFY THE STOPPER SEAL. RESULTS WERE REVIEWED FOR THE REPORTED LOT AND NO ISSUES WERE IDENTIFIED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE LEAKED PAST THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: SOME SYRINGES SHOW LIQUID BETWEEN THE 2 RUBBER BANDS OF THE RUBBER RING OF THE PLUNGER. THESE HAVE BEEN USED AS A WORST-CASE FOR OUR SAMPLES AND WILL BE ANALYZED FOR STERILITY. HOWEVER, WE ALSO IDENTIFIED 2 SYRINGES WHERE LIQUID WAS VISIBLE UNDERNEATH THE PLUNGER. THE STERILITY OF THESE SYRINGES MAY HAVE BEEN IMPACTED. BY EXERTING LATERAL PRESSURE ON THE PLUNGER IT WAS ALSO POSSIBLE TO LET LIQUID FLOW UNDER THE PLUNGER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE LEAKED PAST THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: SOME SYRINGES SHOW LIQUID BETWEEN THE 2 RUBBER BANDS OF THE RUBBER RING OF THE PLUNGER. THESE HAVE BEEN USED AS A WORST-CASE FOR OUR SAMPLES AND WILL BE ANALYZED FOR STERILITY. HOWEVER, WE ALSO IDENTIFIED 2 SYRINGES WHERE LIQUID WAS VISIBLE UNDERNEATH THE PLUNGER. THE STERILITY OF THESE SYRINGES MAY HAVE BEEN IMPACTED. BY EXERTING LATERAL PRESSURE ON THE PLUNGER IT WAS ALSO POSSIBLE TO LET LIQUID FLOW UNDER THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106371 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1910304

    Patients

    Seq Age Sex Outcome Treatment
    1