MAUDE Adverse Event Report: CAREFUSION, INC UNKOWN; GENESIS CONTAINER

Catalog Number UNKNOWN

Device Problem Microbial Contamination of Device (2303)

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

Event Date 10/18/2011

Event Type  malfunction  

Manufacturer Narrative

Pr#: (b)(4).Bd has determined that the genesis¿ sterrad® reusable rigid sterilization containers have not consistently met the requirements for aerosol challenge testing.Failing aerosol data could potentially result in a breach of sterility under conditions outside of normal use as indicated in the instructions for use, which might lead to transmission of infectious pathogens to the surgical patient.This could lead to clinical signs of localized and/or systemic infection including fevers/chills, abscess formation, mild-moderate sepsis, and further worsening if untreated.There have been no reports of adverse events associated with this issue.-field action notification: sur-22-4516-fa.

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: UNKOWN
• Type of Device: GENESIS CONTAINER
• Manufacturer (Section D): CAREFUSION, INC; 17820 englewood dr; cleveland OH 44130
• Manufacturer (Section G): CAREFUSION, INC; 17820 englewood dr; cleveland OH 44130
• Manufacturer Contact: cherie ford ; 17820 englewood dr; cleveland, OH 44130 ; 8015652341
• MDR Report Key: 15633884
• MDR Text Key: 306897860
• Report Number: 1526531-2022-00001
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/19/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2022
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other