BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 16892528 · Received May 8, 2023

    Report

    Report Number
    3003152976-2023-00168
    Event Type
    Malfunction
    Date Received
    May 8, 2023
    Date of Event
    April 17, 2023
    Report Date
    June 9, 2023
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 09-JUN-2023. INVESTIGATION SUMMARY: ONE SAMPLE RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, LEAKAGE PAST THE STOPPER CAN BE OBSERVED. BARREL DO NOT PRESENT ANY DAMAGE THAT COULD HAVE DEFORMED THEIR SHAPE. THE STOPPER IS CORRECTLY ASSEMBLED, WHEN THE SYRINGE IS DISASSEMBLED THE PLUNGER DO NOT SHOW ANY DEFECT. FURTHER TESTING WAS CONDUCTED ON THE SAMPLE, NO SIGN OF LEAKAGE OCCURRED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2212067, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. 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. BASED ON THE INVESTIGATION RESULTS, NO MANUFACTURING RELATED DEFECTS COULD BE IDENTIFIED AND THEREFORE, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    H3: 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 · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGES THE DRUG LEAKED ALONG THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: WHEN PREPARING A SYRINGE, FILLING IT WITH PROPOFOL, THE DRUG LEAKED ALONG THE PLUNGER. THE BLACK SEAL OF THE PLUNGER WAS SOAKED WITH PROPOFOL. THE SYRINGE WAS QUARANTINED FOR MATERIAL VIGILANCE AND A NEW SYRINGE WAS PREPARED (OF THE SAME REFERENCE AND LOT). THE SYRINGE WAS KEPT FOR EXPERTISE. CLINICAL CONSEQUENCES AND CURRENT STATUS OF THE PATIENT OR PERSON INVOLVED: NONE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGES THE DRUG LEAKED ALONG THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: WHEN PREPARING A SYRINGE, FILLING IT WITH PROPOFOL, THE DRUG LEAKED ALONG THE PLUNGER. THE BLACK SEAL OF THE PLUNGER WAS SOAKED WITH PROPOFOL. THE SYRINGE WAS QUARANTINED FOR MATERIAL VIGILANCE AND A NEW SYRINGE WAS PREPARED (OF THE SAME REFERENCE AND LOT). THE SYRINGE WAS KEPT FOR EXPERTISE. CLINICAL CONSEQUENCES AND CURRENT STATUS OF THE PATIENT OR PERSON INVOLVED: NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725483 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2212067

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown