BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 13685513 · Received March 7, 2022

    Report

    Report Number
    3003152976-2022-00089
    Event Type
    Malfunction
    Date Received
    March 7, 2022
    Date of Event
    February 15, 2022
    Report Date
    March 21, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 07-MAR-2022. H.6. INVESTIGATION: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A LEAKAGE PAST THE STOPPER RIBS WAS OBSERVED. THE PRODUCT WAS FURTHER EVALUATED, NO DAMAGED WAS IDENTIFIED IN THE BARREL OR OTHER COMPONENTS THAT COULD HAVE CAUSED A LEAK AND THE STOPPER WAS VERIFIED TO BE PROPERLY ASSEMBLED ONTO THE PLUNGER ROD. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2110092, 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. THE RETURNED SAMPLE UNDERWENT THE SAME TESTS AND PRODUCT MET REQUIRED SPECIFICATIONS. GIVEN THAT WE DID NOT OBSERVE ANY DEFECT WITHIN THE SYRINGE THAT COULD HAVE CAUSED THE LEAK, WE CANNOT IDENTIFY A DEFINITIVE ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE LEAKED PAST THE PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "DURING THE RECONSTITUTION OF CYTOTOXICS, SAMPLING OF EPPI WITH THE SYRINGE. OBSERVATION OF A LEAK AT THE LEVEL OF THE PLUNGER (VISIBLE ABOVE THE PLUNGER). NO PRESENCE OF CYTOTOXIC PRODUCT IN THE SYRINGE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE LEAKED PAST THE PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "DURING THE RECONSTITUTION OF CYTOTOXICS, SAMPLING OF EPPI WITH THE SYRINGE. OBSERVATION OF A LEAK AT THE LEVEL OF THE PLUNGER (VISIBLE ABOVE THE PLUNGER). NO PRESENCE OF CYTOTOXIC PRODUCT IN THE SYRINGE.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338531 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2110092

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown