BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 11573138 · Received March 25, 2021

    Report

    Report Number
    3003152976-2021-00169
    Event Type
    Malfunction
    Date Received
    March 25, 2021
    Date of Event
    March 2, 2021
    Report Date
    April 16, 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

    INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2010099, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 2010099 WERE USED TO CONDUCT A LEAKAGE TEST. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS NOTED, THE STOPPER WAS PROPERLY ASSEMBLED ONTO THE PLUNGER ROD, AND NO LEAK WAS OBSERVED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CHEMOTHERAPY MEDICINE LEAKED FROM 4 SEPARATE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGES DURING USE. IN ONE CASE, A MEMBER OF PERSONNEL WAS EXPOSED TO THE CYTOTOXIC MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "WE HAVE ENCOUNTERED 4 TIMES A LEAKAGE PROBLEM ON THE 50ML SYRINGES REF (B)(4) (BATCH 2010099). DURING SAMPLING, A LOSS OF PISTON RESISTANCE IS FELT. WHEN INJECTING, A LIQUID OUTLET OCCURS AT THE PISTON. THE DEVICES CONCERNED THAT HAVE BEEN IN CONTACT WITH CYTOTOXIC PRODUCTS HAVE NOT BEEN KEPT." "THE INCIDENT RESULTED IN LEAKAGE OF CYTOTOXIC PRODUCT AND THUS EXPOSURE OF THE PERSONNEL IN THE CHEMOTHERAPY PREPARATION UNIT. IN ONE OF THESE CASES, THE LEAK RESULTED IN THE NEED TO RESTART THE PREPARATION WITH THE USE OF A NEW VIAL OF MEDICINE AT A COST OF 3076¿."

    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 CHEMOTHERAPY MEDICINE LEAKED FROM 4 SEPARATE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGES DURING USE. IN ONE CASE, A MEMBER OF PERSONNEL WAS EXPOSED TO THE CYTOTOXIC MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "WE HAVE ENCOUNTERED 4 TIMES A LEAKAGE PROBLEM ON THE 50ML SYRINGES REF 300865 (BATCH 2010099). DURING SAMPLING, A LOSS OF PISTON RESISTANCE IS FELT. WHEN INJECTING, A LIQUID OUTLET OCCURS AT THE PISTON. THE DEVICES CONCERNED THAT HAVE BEEN IN CONTACT WITH CYTOTOXIC PRODUCTS HAVE NOT BEEN KEPT." "THE INCIDENT RESULTED IN LEAKAGE OF CYTOTOXIC PRODUCT AND THUS EXPOSURE OF THE PERSONNEL IN THE CHEMOTHERAPY PREPARATION UNIT. IN ONE OF THESE CASES, THE LEAK RESULTED IN THE NEED TO RESTART THE PREPARATION WITH THE USE OF A NEW VIAL OF MEDICINE AT A COST OF 3076¿."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469609 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2010099

    Patients

    Seq Age Sex Outcome Treatment
    1 Other