BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 12132376 · Received July 7, 2021

    Report

    Report Number
    3003152976-2021-00366
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    June 8, 2021
    Report Date
    August 2, 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

    H6: INVESTIGATION SUMMARY ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION OF THE SAMPLE, A LEAKAGE PAST THE STOPPER RIBS WAS OBSERVED. THE PRODUCT WAS FURTHER EVALUATED, THERE WAS NO DAMAGE NOTED IN THE PLUNGER ROD AND THE STOPPER WAS VERIFIED TO BE PROPERLY ASSEMBLED, HOWEVER, THERE WAS DAMAGE OBSERVED ON THE SYRINGE BARREL, THE STOPPER NOT PROPERLY SEALED WHEN MOVING ACROSS THIS AREA. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2012070, 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. LEAKAGE TESTING WAS PERFORMED ON THE RETURNED SAMPLE AND PRODUCT WAS FOUND TO MEET REQUIRED SPECIFICATIONS. BASED ON THE SAMPLE EVALUATION, IT WAS DETERMINED THE LEAK IS A RESULT OF THE DAMAGED OBSERVED WITHIN THE SYRINGE. WHILE THE DAMAGE LIKELY OCCURRED DURING MANUFACTURING, A SPECIFIC ROOT CAUSE OF THE DAMAGE COULD NOT BE IDENTIFIED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LIQUID LEAKED PAST THE STOPPER IN THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE WHEN DRAWING IT UP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: "WHEN PULLING UP LIQUID WITH THE 50 ML SYRINGES (LOT 2012070), LIQUID IS PULLED INTO THE BLACK RUBBER CAUSING THE SYRINGE TO LEAK ALONG THE STOPPER. THIS HAS ALREADY LED TO VERY DANGEROUS SITUATIONS DURING THE PREPARATION OF CHEMOTHERAPY.".

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LIQUID LEAKED PAST THE STOPPER IN THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE WHEN DRAWING IT UP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: "WHEN PULLING UP LIQUID WITH THE 50 ML SYRINGES (LOT 2012070), LIQUID IS PULLED INTO THE BLACK RUBBER CAUSING THE SYRINGE TO LEAK ALONG THE STOPPER. THIS HAS ALREADY LED TO VERY DANGEROUS SITUATIONS DURING THE PREPARATION OF CHEMOTHERAPY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025919 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2012070

    Patients

    Seq Age Sex Outcome Treatment
    1