BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK SYRINGE

    MDR report key: 8612545 · Received May 15, 2019

    Report

    Report Number
    3003152976-2019-00323
    Event Type
    Malfunction
    Date Received
    May 15, 2019
    Date of Event
    April 29, 2019
    Report Date
    June 7, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    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: ONE SAMPLE WAS RETURNED TO OUR QUALITY ENGINEER FOR INVESTIGATION. THROUGH VISUAL INSPECTION, DAMAGE WAS OBSERVED ON THE SYRINGE BARREL BETWEEN THE 15ML AND 20ML MARKINGS. THE BARREL IS DENTED IN THIS AREA CAUSING THE STOPPER TO BECOME DISTORTED WHEN MOVED ACROSS THIS POINT, WHICH LEAD TO THE LEAK THAT WAS REPORTED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 1902235 AND FOUND NO NON-CONFORMANCES OR MAINTENANCE INTERVENTIONS RELATED TO THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. PRODUCT UNDERGOES VISUAL AND FUNCTIONAL TESTING THROUGHOUT THE MANUFACTURING PROCESS. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THIS INCIDENT OCCURRED AS A RESULT OF THE SYRINGE GETTING JAMMED IN THE MANUFACTURING EQUIPMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ SYRINGE LEAKED ALONG THE PLUNGER IN THE BODY OF THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN FILLING THE SYRINGE, IT HAS BEEN NOTICED A LEAKAGE ALONG THE PLUNGER IN THE BODY OF THE SYRINGE. THIS DEFECT CAUSED A LOSS OF PRODUCT. NEED TO USE ANOTHER DEVICE. USERS TOLD US THAT THIS INCIDENT HAD ALREADY BEEN REPORTED 3 TIMES THIS MONTH. THE SYRINGE CONTAINED SALINE SOLUTION (PHYSIOLOGIC SERUM) NACL 0.09% FOR THE PREPARATION OF AN ANTIBIOTIC (NOT PRESENT IN THE SYRINGE).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PLASTIPAK¿ SYRINGE LEAKED ALONG THE PLUNGER IN THE BODY OF THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN FILLING THE SYRINGE, IT HAS BEEN NOTICED A LEAKAGE ALONG THE PLUNGER IN THE BODY OF THE SYRINGE. THIS DEFECT CAUSED A LOSS OF PRODUCT. NEED TO USE ANOTHER DEVICE. USERS TOLD US THAT THIS INCIDENT HAD ALREADY BEEN REPORTED 3 TIMES THIS MONTH. THE SYRINGE CONTAINED SALINE SOLUTION (PHYSIOLOGIC SERUM) NACL 0.09% FOR THE PREPARATION OF AN ANTIBIOTIC (NOT PRESENT IN THE SYRINGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404036 BD PLASTIPAK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1902235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other