BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED BD ALARIS PUMP SET

    MDR report key: 11681326 · Received April 16, 2021

    Report

    Report Number
    2243072-2021-01188
    Event Type
    Injury
    Date Received
    April 16, 2021
    Date of Event
    March 19, 2021
    Report Date
    May 21, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY THIS COMPLAINT WAS RAISED DUE TO THE CUSTOMER INDICATING THAT THEY HAD EXPERIENCED UNSOLVED INFECTION EVENTS WHICH THEY SUSPECT MIGHT BE LINKED TO THE RECENT FIELD SAFETY CORRECTIVE ACTION (FSCA) - MDS-21-4072. IN THIS INSTANCE, FURTHER DETAILS PERTAINING TO THE ALLEGED INFECTION EVENTS HAVE NOT BEEN PROVIDED TO ASSIST THE INVESTIGATION AND THEREFORE IT WAS NOT POSSIBLE TO DETERMINE IF THE UNSOLVED INFECTION EVENTS MAY HAVE BEEN LINKED TO THE STERILITY OF THE BD PRODUCTS. IN PARTICULAR, NO SPECIFIC MODEL CODES OR LOT NUMBERS ARE AVAILABLE. THIS COMPLAINT HAS BEEN LINKED TO MDS-21-4072-SA, HOWEVER THERE WAS NO EVIDENCE THAT THIS WAS COMPLAINT WAS LINKED TO THE STERILIZATION ISSUE. CAPA NUMBER (B)(6). BD IS PERFORMING A FSCA BASED ON A NOTIFICATION FROM A 3RD PARTY STERILISATION PROVIDER THAT THEY HAD INTENTIONALLY FALSIFIED STERILISATION PROCESS RECORDS. ALTHOUGH BD HAS TAKEN THIS ACTION, PLEASE NOTE THAT THERE HAVE BEEN NO CONFIRMED COMPLAINTS RELATING TO THE STERILITY OF THE PRODUCTS INCLUDED IN THE FSN TO-DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD ALARIS¿ PUMP SET HAD STERILITY ISSUES CONNECTED TO "UNSOLVED INFECTION EVENTS". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THEY HAD AN AREA IN THE HOSPITAL WITH A UNSOLVED INFECTION EVENTS, WHERE MANY OF THE ALARIS SETS ARE IN USE." "UNSTERILE PRODUCTS MIGHT BE THE CAUSE OF THOSE INFECTION EVENTS."

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND (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: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD ALARIS¿ PUMP SET HAD STERILITY ISSUES CONNECTED TO "UNSOLVED INFECTION EVENTS". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THEY HAD AN AREA IN THE HOSPITAL WITH A UNSOLVED INFECTION EVENTS, WHERE MANY OF THE ALARIS SETS ARE IN USE". "UNSTERILE PRODUCTS MIGHT BE THE CAUSE OF THOSE INFECTION EVENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577467 UNSPECIFIED BD ALARIS PUMP SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other