BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA CLOSED IV CATHETER SYSTEM 22 GA 1.00 IN (DUAL PORT W/CAP)

    MDR report key: 11704347 · Received April 21, 2021

    Report

    Report Number
    1213809-2021-00255
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 25, 2021
    Report Date
    June 1, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 2021-05-10. INVESTIGATION SUMMARY: THREE LOOSE 3ML SYRINGES WERE RECEIVED AND EVALUATED. IT WAS OBSERVED, EACH OF THE SYRINGES HAD PORTIONS OF GRAD LINES MISSING THROUGHOUT THE ENTIRE SCALE, WHICH WERE REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH: 8142980 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD LUER-LOK¿ 3ML SYRINGES EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BATCH: 8142980 INCOMPLETE SCALE: 3 SYRINGES DEFECT SYRINGES WERE FOUND DURING PACKAGING, AT THE END OF EACH BATCH.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 3 BD LUER-LOK¿ 3ML SYRINGES EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BATCH: 8142980. INCOMPLETE SCALE: 3 SYRINGES. DEFECT SYRINGES WERE FOUND DURING PACKAGING, AT THE END OF EACH BATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601684 BD NEXIVA CLOSED IV CATHETER SYSTEM 22 GA 1.00 IN (DUAL PORT W/CAP) PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8142980

    Patients

    Seq Age Sex Outcome Treatment
    1