BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 20ML SYRINGE LUER-LOK

    MDR report key: 8791678 · Received July 15, 2019

    Report

    Report Number
    3003152976-2019-00463
    Event Type
    Malfunction
    Date Received
    July 15, 2019
    Date of Event
    June 24, 2019
    Report Date
    August 8, 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: TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE PLUNGER OF THE SYRINGE IS OBSERVED TO BE BROKEN. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 1902267, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCT UNDERGOES A SERIES OF TESTING AND INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. ALTHOUGH WE COULD NOT IDENTIFY A DIRECT CAUSE, IT WAS DETERMINED THIS INCIDENT LIKELY OCCURRED DUE TO THE PLUNGER GETTING JAMMED WITHIN IN THE MANUFACTURING EQUIPMENT, DAMAGING THE PLUNGER AND RESULTING IN THE PLUNGER BREAKING UPON USE. THE DAMAGE ALSO COULD HAVE OCCURRED DURING THE TRANSPORT PROCESSES. BASED ON THE PREVENTIVE MEASURES IN PLACE AND THE CURRENT INSPECTION PROCESS, THIS IS BELIEVED TO BE AN ISOLATED ISSUE WITH AN UNLIKELY RECURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INJECTION THE PLUNGER BROKE WITH A BD PLASTIPAK¿ 20ML SYRINGE LUER-LOK¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: 72-YEAR-OLD PATIENT, THE SYRINGE PLUNGER BROKE DURING AN INJECTION. SYRINGE CHANGED.

    Additional Manufacturer Narrative · 1

    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 DURING INJECTION THE PLUNGER BROKE WITH A BD PLASTIPAK¿ 20ML SYRINGE LUER-LOK¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: (B)(6) YEAR OLD PATIENT, THE SYRINGE PLUNGER BROKE DURING AN INJECTION. SYRINGE CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584204 BD PLASTIPAK 20ML SYRINGE LUER-LOK SYRINGE FMF BECTON DICKINSON, S.A. 1902267

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other