BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPACK¿ 20ML SYRINGE

    MDR report key: 6773630 · Received August 8, 2017

    Report

    Report Number
    3003916417-2017-00012
    Event Type
    Malfunction
    Date Received
    August 8, 2017
    Date of Event
    July 13, 2017
    Report Date
    September 6, 2017
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: ACCORDING THE PRELIMINARY EVALUATION THE DEFECT IS RELATED TO THE MOLDING PROCESS. THIS TYPE OF FOREIGN MATTER CAN BE CAUSED BY RUBBISH REMOVAL OF THE INJECTION PUMP, IT CAN GO TO THE MOLD AND IT WILL BE INJECTED WITH THE PRODUCT. DURING THE BARREL BATCH PRODUCTION, NO OCCURRENCE RECORD (RO) WAS IDENTIFIED FOR BATCH AND DEFECT IN QUESTION. IT WAS VERIFIED THAT THE PROBLEM IS PUNCTUAL, CAUSED BY RUBBISH REMOVAL OF INJECTION PUMP. THIS PRODUCT PASS ACTUALLY PER A RESIN CHANGE PROCESS THAT WITH THE NEW RESIN THIS DEFECT IS REDUCED/ELIMINATED (BECAUSE THE MATERIAL FLUIDITY). VISUAL TEST: THE SAMPLE SHOWS FOREIGN MATTER IN THE BARREL NOZZLE.

    Additional Manufacturer Narrative · 1

    . DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE #: (B)(6). PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. UDI #: (B)(4).

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 7073640. ACCORDING THE PRELIMINARY EVALUATION THE DEFECT IS RELATED TO THE MOLDING PROCESS. THIS TYPE OF FOREIGN MATTER CAN BE CAUSED BY RUBBISH REMOVAL OF THE INJECTION PUMP, IT CAN GO TO THE MOLD AND IT WILL BE INJECTED WITH THE PRODUCT. DURING THE BARREL BATCH PRODUCTION, NO OCCURRENCE RECORD (RO) WAS IDENTIFIED FOR BATCH AND DEFECT IN QUESTION. IT WAS VERIFIED THAT THE PROBLEM IS PUNCTUAL, CAUSED BY RUBBISH REMOVAL OF INJECTION PUMP. THIS PRODUCT PASS ACTUALLY PER A RESIN CHANGE PROCESS THAT WITH THE NEW RESIN THIS DEFECT IS REDUCED/ELIMINATED (BECAUSE THE MATERIAL FLUIDITY). VISUAL TEST THE SAMPLE SHOWS FOREIGN MATTER IN THE BARREL NOZZLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DIRT WAS FOUND ON THE TIP OF THE BD PLASTIPACK¿ 20ML SYRINGE BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554403 BD PLASTIPACK¿ 20ML SYRINGE CONVENTIONAL SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 7073640

    Patients

    Seq Age Sex Outcome Treatment
    1 Other