BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INJECTION SITE

    MDR report key: 14162250 · Received April 20, 2022

    Report

    Report Number
    2243072-2022-00515
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    March 29, 2022
    Report Date
    July 18, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A COMPLAINT OF COMPONENT OCCLUSION WAS RECEIVED FROM THE CUSTOMER. SAMPLES WERE SENT TO NAMC, BUT WERE UNAVAILABLE FOR REVIEW. THE PRODUCT REPORTED WAS MANUFACTURED BY SUPPLIER AND MANUFACTURING INFORMATION WAS REQUESTED. THE MOLD WAS TRANSFERRED FROM VYAIRE TO THE NORTH AMERICAN MOLDING CENTER. IT WAS DISASSEMBLED, INSPECTED AND CLEANED. THESE INSPECTIONS AND IF NECESSARY, CORRECTIONS ARE DONE TO ALL VYAIRE TRANSFER MOLD RECEIVED AT THE NAMC BEFORE THE MOLD RUNS. THE SUPPLIER CONDUCTED A DHR REVIEW AND NO ISSUES WERE FOUND DURING THE MANUFACTURING OF THE REPORTED LOT. SINCE THE MOLD WAS TRANSFERRED AND NO ISSUES WERE FOUND DURING MANUFACTURING, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE MOLDING AND TOOLING ENGINEERING WAS PERFORMED AND IT CONCLUDED THAT A POSSIBLE CAUSE FOR THIS DEFECT IS A BROKEN PIN. NAMC HAS PROCESS CONTROLS IN PLACE THAT WOULD DETECT SYSTEMIC DEFECTS LEADING TO THIS FAILURE MODE. THE INSPECTION AND CONTROL PROCESSES AT NAMC ARE DESIGNED TO DETECT, CONTAIN AND PREVENT RELEASE OF THIS AND ALL DEFINED DEFECTS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED 29 BD INJECTION SITES HAD DEFECTIVE NACL CONNECTORS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NACL CONNECTORS ARE DEFECT. A PART OF THE DEFECTS WERE DUE TO THE FACT THAT THE OPENING FOR THE NACL TO FLOW THROUGH WAS CLOSED IN THE CONNECTING PIECE OF THE BAG (NO OPENING PRESENT)."

    Description of Event or Problem · 0

    IT WAS REPORTED 29 BD INJECTION SITES HAD DEFECTIVE NACL CONNECTORS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NACL CONNECTORS ARE DEFECT. A PART OF THE DEFECTS WERE DUE TO THE FACT THAT THE OPENING FOR THE NACL TO FLOW THROUGH WAS CLOSED IN THE CONNECTING PIECE OF THE BAG (NO OPENING PRESENT)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272708 BD INJECTION SITE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 0004120714

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown