BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 11593710 · Received March 30, 2021

    Report

    Report Number
    3003152976-2021-00178
    Event Type
    Injury
    Date Received
    March 30, 2021
    Date of Event
    March 5, 2021
    Report Date
    May 5, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10/D11: CONCOMITANT MEDICAL PRODUCTS: DEVICE AVAILABLE FOR EVAL?: YES. D10/D11: CONCOMITANT MEDICAL PRODUCTS: RETURNED TO MANUFACTURER ON: 3/29/2021. H.6. INVESTIGATION: ONE USED SAMPLE WAS RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, NO LEAKAGE PAST THE STOPPER RIBS WAS OBSERVED. THE PRODUCT WAS DISASSEMBLED FOR FURTHER INSPECTION, THERE WAS NO DAMAGE OR MOLDING DEFECTS NOTED IN THE PLUNGER ROD 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 LOT 2010099, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE EXPERIENCED LEAKAGE AND LED TO CHEMOTHERAPY DRUG EXPOSURE. IT HAS NOT BEEN SPECIFIED WHETHER MEDICAL INTERVENTION WAS ADMINISTERED AS A RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AS MENTIONED BY TELEPHONE, WE HAVE AGAIN NOTICED A LEAK IN THE PLUNGER OF A 50ML SYRINGE REF 300865 (BATCH 2010099). THIS TIME THE SYRINGE HAS BEEN KEPT AND CAN BE SENT TO YOU FOR EXPERTISE. HOWEVER, THE INCIDENT OCCURRED DURING THE PREPARATION OF AN EXPENSIVE CYTOTOXIC PRODUCT. DUE TO THE DEFECT IN THE SYRINGE, THE CHEMOTHERAPY HAD TO BE RE-PREPARED. THE INCIDENT RESULTED IN LEAKAGE OF CYTOTOXIC PRODUCT AND THUS EXPOSURE OF THE PERSONNEL IN THE CHEMOTHERAPY PREPARATION UNIT. IN ONE OF THESE CASES.

    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 THE BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE EXPERIENCED LEAKAGE AND LED TO CHEMOTHERAPY DRUG EXPOSURE. IT HAS NOT BEEN SPECIFIED WHETHER MEDICAL INTERVENTION WAS ADMINISTERED AS A RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AS MENTIONED BY TELEPHONE, WE HAVE AGAIN NOTICED A LEAK IN THE PLUNGER OF A 50ML SYRINGE REF 300865 (BATCH 2010099). THIS TIME THE SYRINGE HAS BEEN KEPT AND CAN BE SENT TO YOU FOR EXPERTISE. HOWEVER, THE INCIDENT OCCURRED DURING THE PREPARATION OF AN EXPENSIVE CYTOTOXIC PRODUCT. DUE TO THE DEFECT IN THE SYRINGE, THE CHEMOTHERAPY HAD TO BE RE-PREPARED. THE INCIDENT RESULTED IN LEAKAGE OF CYTOTOXIC PRODUCT AND THUS EXPOSURE OF THE PERSONNEL IN THE CHEMOTHERAPY PREPARATION UNIT. IN ONE OF THESE CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489892 BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 2010099

    Patients

    Seq Age Sex Outcome Treatment
    1 Other