BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML SYRINGE

    MDR report key: 13048474 · Received December 20, 2021

    Report

    Report Number
    3003152976-2021-00839
    Event Type
    Malfunction
    Date Received
    December 20, 2021
    Date of Event
    November 24, 2021
    Report Date
    February 7, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 12/15/2021. H.6. INVESTIGATION: SIXTY UNUSED SAMPLES RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION, STOPPER IS CORRECTLY ASSEMBLED IN ALL OF THEM. EXAMINED SYRINGES DO NOT PRESENT ANY DAMAGE IN THE BARREL THAT COULD LEAD TO THE LEAKAGE EXPERIENCED BY CUSTOMER. TEN SYRINGES HAVE BEEN DISASSEMBLED TO EXAMINE PARTS SEPARATELY AND NO DEFECT HAS BEEN DETECTED RELATED TO THE LEAKAGE DESCRIBED. LEAKAGE TEST IS PERFORMED ON TEN SAMPLES, NO ISSUES OR LEAK OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2001208, 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. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE #: (B)(6). INITIAL REPORTER FAX #: (B)(6). 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 THE BD PLASTIPAK 50ML SYRINGE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR CUSTOMER SERVICE RECEIVED A COMPLAINT ABOUT PLASTIPAK SYRINGES WITH LEAKAGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK 50ML SYRINGE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR CUSTOMER SERVICE RECEIVED A COMPLAINT ABOUT PLASTIPAK SYRINGES WITH LEAKAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1943678 BD PLASTIPAK 50ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 2001208

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown