BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 8883974 · Received August 12, 2019

    Report

    Report Number
    3003152976-2019-00529
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    July 4, 2019
    Report Date
    September 27, 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

    H.6. INVESTIGATION SUMMARY: TWO SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE THUMB PRESS IS OBSERVED TO BE BROKEN. WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. A BATCH HISTORY REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF LOT 1905227. 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. AREAS WHERE PRODUCT IS MOVED THROUGH THE MANUFACTURING EQUIPMENT IS PROTECTED TO AVOID DAMAGING THE PRODUCT. A PROJECT HAS BEEN INITIATED TO LOOK FURTHER INTO THIS ISSUE AND REDUCE ANY REOCCURRENCE. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE PLUNGER WAS BROKEN. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 BROKEN SYRINGES ON THE PLUNGER.

    Additional Manufacturer Narrative · 1

    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¿ 50ML CONCENTRIC LUER LOCK SYRINGE PLUNGER WAS BROKEN. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 BROKEN SYRINGES ON THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678312 BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1905227

    Patients

    Seq Age Sex Outcome Treatment
    1 Other