BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE® SYRINGE NEEDLES

    MDR report key: 7889690 · Received September 19, 2018

    Report

    Report Number
    3003916417-2018-00232
    Event Type
    Malfunction
    Date Received
    September 19, 2018
    Date of Event
    August 29, 2018
    Report Date
    October 31, 2018
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SAMPLE RELATED TO THE OCCURRENCE WAS RECEIVED. THE ANALYSIS LED TO CONFIRMATION OF THE REPORTED FAILURE. DHR REVIEW: 8163582 - IT WAS VERIFIED THE BATCH RECORD AND THE MANUFACTURING DATE FOR THIS BATCH WAS JUNE 13TH ¿ 25TH, 2018. THE PROCESS INSPECTIONS WERE PERFORMED AT PROPERLY FREQUENCY AND NO RECORDS OF THIS DEFECT WERE FOUND. 6194225 - IT WAS VERIFIED THE BATCH RECORD AND THE MANUFACTURING DATE FOR THIS BATCH WAS AUGUST 13TH, 2016. THE PROCESS INSPECTIONS WERE PERFORMED AT PROPERLY FREQUENCY AND NO RECORDS OF THIS DEFECT WERE FOUND. 6118050 - IT WAS VERIFIED THE BATCH RECORD AND THE MANUFACTURING DATE FOR THIS BATCH WAS MAY 25TH, 2016. THE PROCESS INSPECTIONS WERE PERFORMED AT PROPERLY FREQUENCY AND NO RECORDS OF THIS DEFECT WERE FOUND. 6118052 ¿ IT WAS VERIFIED THE BATCH RECORD AND THE MANUFACTURING DATE FOR THIS BATCH WAS MAY 25TH, 2016. THE PROCESS INSPECTIONS WERE PERFORMED AT PROPERLY FREQUENCY AND NO RECORDS OF THIS DEFECT WERE FOUND. 6151421- IT WAS VERIFIED THE BATCH RECORD AND THE MANUFACTURING DATE FOR THIS BATCH WAS JUNE 06TH, 2016. THE PROCESS INSPECTIONS WERE PERFORMED AT PROPERLY FREQUENCY AND NO RECORDS OF THIS DEFECT WERE FOUND. QN REVIEW: NO QUALITY RECORDS RELATED TO THIS BATCH AND FAILURE MODE WERE OBSERVED. MAINTENANCE REVIEW: NO MAINTENANCE RECORDS RELATED TO THIS BATCH WERE OBSERVED. THE ROOT CAUSE FOR THIS FAILURE MODE OCCURRED DUE TO A SCREWING OF THE GUN WITH CANNULA SHIELD AND CANNULA HUB. AT THIS STEP OF ASSEMBLY PROCESS A MISALIGNMENT BETWEEN SHIELD AND HUB CAUSED THE HUB FRACTURE. THE MANUFACTURING PROCESS ARE VALIDATED WITH DEFINED ACCEPTANCE CRITERIA. THE INCIDENT IDENTIFIED BY THIS COMPLAINT WILL BE MONITORED TO TENDENCY ANALYSIS. CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD PRECISIONGLIDE® SYRINGE NEEDLE HAD A HOLE IN IT. THERE WAS NO REPORT OF EXPOSURE TO MUCOSAL MEMBRANES, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    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 A BD PRECISIONGLIDE® SYRINGE NEEDLE HAD A HOLE IN IT. THERE WAS NO REPORT OF EXPOSURE TO MUCOSAL MEMBRANES, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729741 BD PRECISIONGLIDE® SYRINGE NEEDLES NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA 8163582

    Patients

    Seq Age Sex Outcome Treatment
    1 Other