MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY / CAREFUSION 2200, INC. GENESIS STERILIZATION CONTAINER; TRAY, SURGICAL, INSTRUMENT

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2011

Event Type  Injury  

Event Description

Genesis surgical instrument sterilization containers from becton dickinson and company of (b)(4), experienced a 10-50% contamination breach failure in the fda required "aerosol test".Bd and carefusion, since 2011, have failed to report this safety breach defect to the fda in violation of federal law.Fda safety report id# (b)(4).

• Brand Name: GENESIS STERILIZATION CONTAINER
• Type of Device: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY / CAREFUSION 2200, INC.
• MDR Report Key: 15380550
• MDR Text Key: 299584467
• Report Number: MW5111921
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening