BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPACK¿ SYRINGE

    MDR report key: 7505244 · Received May 10, 2018

    Report

    Report Number
    3003916417-2018-00078
    Event Type
    Malfunction
    Date Received
    May 10, 2018
    Date of Event
    April 24, 2018
    Report Date
    May 21, 2018
    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 · 0

    INVESTIGATION SUMMARY: SAMPLES/ PHOTOS ANALYSIS: DUE TO THE SEVERITY OF THE PROBLEM, BD WILL BE USING EVALUATIONS ALREADY PERFORMED ON COMPLAINT SAMPLES INCLUDING FUNCTIONAL TESTS THAT WERE PERFORMED. DHR REVIEW: THE BATCH RECORD WAS VERIFIED AND THE PROCESS INSPECTIONS WERE PERFORMED AT PROPER FREQUENCY. QN REVIEW: NO QUALITY NOTIFICATION (QN) WERE FOUND IN THE BATCH INFORMED. MAINTENANCE REVIEW: NO MAINTENANCE RECORD WERE FOUND. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO CONFIRM/ REPRODUCE THE INCIDENT IN QUESTION. WE INFORM FOR BD PRODUCTS ALL THE PRODUCTION PROCESSES ARE VALIDATED ACCORDING TO ESTABLISHED CRITERIA TO THE FULFILLMENT OF THE USERS¿ REQUIREMENTS. ACCORDING TO THE INTERNAL BD PROCEDURES FOR THE SITUATION, A RESEARCH PROCESS WAS INITIATED INVOLVING BD BRAZIL AND UNITED STATES TEAM IN ORDER TO EVALUATE THE POTENTIAL CAUSES FOR THE OCCURRENCE OF THE REPORTED DEFECT. AS PART OF THIS PROCESS WE OPENED THE CAPA # (B)(4) AND SITUATION ANALYSIS # (B)(4). AMONG THE ACTIVITIES PLANNED FOR THE INVESTIGATION PROCESS OF THE PROBLEM ARE THE FOLLOWING EVALUATIONS: DEVELOPMENT OF AN ANALYTICAL METHOD TO MEASURE THE TIP CIRCUMFERENCE DEFORMATION WITH ACCURACY; INCLUDE IN PRODUCT DRAFT A SPECIFICATION AS TO THE TIP CIRCUMFERENCE TO BE MONITORED DURING THE MANUFACTURING PROCESS; PARAMETERS AND MOLD CHANGES TO GUARANTEE THE PRODUCT SPECIFICATION CHANGES IN ORDER TO CORRECT THE TIP DEFORMITY. ACCORDING THE INVESTIGATION PLAN AND TEST RESULTS UNTIL NOW, THE POTENTIAL CAUSE TO THIS PROBLEM IS RELATED TO DEFORMITY AT SYRINGE TIP DUE THE PRODUCTION PROCESS OF THE MATERIAL IN MOLDING STEP.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. "THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7270765. MEDICAL DEVICE EXPIRATION DATE: 09/30/2022. DEVICE MANUFACTURE DATE: 09/29/2017. MEDICAL DEVICE LOT #: 7300625. MEDICAL DEVICE EXPIRATION DATE: 10/31/2022. DEVICE MANUFACTURE DATE: 10/31/2017. MEDICAL DEVICE LOT #: 7270764. MEDICAL DEVICE EXPIRATION DATE: 10/31/2022. DEVICE MANUFACTURE DATE: 10/31/2017. MEDICAL DEVICE LOT #: 7229821. MEDICAL DEVICE EXPIRATION DATE: 08/31/2022. DEVICE MANUFACTURE DATE: 09/02/2017. MEDICAL DEVICE LOT #: 7115835 . MEDICAL DEVICE EXPIRATION DATE: 04/30/2022. DEVICE MANUFACTURE DATE: 04/28/2017. MEDICAL DEVICE LOT #: 7016955. MEDICAL DEVICE EXPIRATION DATE: 12/31/2021. DEVICE MANUFACTURE DATE: 01/16/2017. MEDICAL DEVICE LOT #: 7173511. MEDICAL DEVICE EXPIRATION DATE: 06/30/2022. DEVICE MANUFACTURE DATE: 06/30/2017. MEDICAL DEVICE LOT #: 7173510. MEDICAL DEVICE EXPIRATION DATE: 06/30/2022. DEVICE MANUFACTURE DATE: 06/30/2017. MEDICAL DEVICE LOT #: 6302987. MEDICAL DEVICE EXPIRATION DATE: 10/31/2021. DEVICE MANUFACTURE DATE: 11/01/2016. MEDICAL DEVICE LOT #: 7300622. MEDICAL DEVICE EXPIRATION DATE: 10/31/2022. DEVICE MANUFACTURE DATE: 10/31/2017. MEDICAL DEVICE LOT #: 7333775. MEDICAL DEVICE EXPIRATION DATE: 11/30/2022. DEVICE MANUFACTURE DATE: 11/30/2017. MEDICAL DEVICE LOT #: 7300630. MEDICAL DEVICE EXPIRATION DATE: 10/31/2022. DEVICE MANUFACTURE DATE: 10/31/2017. 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 THE BD PLASTIPACK¿ SYRINGE HAD NO VACUUM. AIR ENTRANCE DURING BLOOD COLLECTION AND HEMOLYSIS OF SAMPLES. FOUND DURING USE, DURING A BLOOD COLLECTION. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347767 BD PLASTIPACK¿ SYRINGE SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other