BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE

    MDR report key: 16710342 · Received April 10, 2023

    Report

    Report Number
    3003152976-2023-00126
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    March 21, 2023
    Report Date
    May 30, 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

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2212074. D.4. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2027. H.4. DEVICE MANUFACTURE DATE: 05-DEC-2022. D.4. MEDICAL DEVICE LOT #: 2205038. D.4. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2027. H.4. DEVICE MANUFACTURE DATE: 27-APR-2022.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO SAMPLE OR PHOTO RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2212074, 2205038 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. RETAINED SAMPLES FROM THE SAME LOTS WERE EVALUATED. THE STOPPER IS CORRECTLY ASSEMBLED, WHEN THE SYRINGE IS DISASSEMBLED THE PLUNGER DOES NOT SHOW ANY DEFECT. FURTHER TESTING WAS CONDUCTED, NO SIGN OF LEAKAGE OCCURRED. 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 QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 OF THE BD PLASTIPAK¿ SYRINGE EXPERIENCED LEAKAGE. THIS REPORT IS FOR PATIENT 1 OF 2. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE DEVICE IS USED FOR CHEMOTHERAPY BUT THE SEALS ARE LOOSE, THE PRODUCT IS LEAKING / THE DEVICE IS NOT WORKING. THE CHEMO PRODUCTS HAVE THEREFORE LEAKED ON THE 2 PREPARERS TWICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 OF THE BD PLASTIPAK¿ SYRINGE EXPERIENCED LEAKAGE. THIS REPORT IS FOR PATIENT 1 OF 2. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE DEVICE IS USED FOR CHEMOTHERAPY BUT THE SEALS ARE LOOSE, THE PRODUCT IS LEAKING / THE DEVICE IS NOT WORKING. THE CHEMO PRODUCTS HAVE THEREFORE LEAKED ON THE 2 PREPARERS TWICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820015 BD PLASTIPAK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female