MAUDE Adverse Event Report: STERIS CANADA ULC 3 LEVEL MANIFOLD RACK; RACK TO WASHER

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Abrasion (1689)

Event Date 10/20/2021

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the rack and no issues were noted.The rack was found to be operating according to specification; no repairs were required.While onsite, the technician was informed by user facility personnel that the employee had picked up the loaded rack by the metal edges of the rack instead of using the silicone protected handles and a transfer cart.The employee later realized he obtained an injury to his finger.The amsco 7053l washer/disinector operator manual states, "use a transfer cart to bring fully loaded basket or accessory rack next to washer/disinfector load door".Although the rack was to specification and no repairs were required, the technician buffed the edges on the rack per the customers request.The technician counseled user facility personnel on the proper use and operation of the 3 level manifold rack, specifically using a transfer cart when moving a loaded rack.No additional issues have been reported.

Event Description

The user facility reported that an employee obtained a cut on their finger while loading a 3 level manifold rack into their washer.Medical treatment was sought.The employee self-applied a bandage to their hand.

• Brand Name: 3 LEVEL MANIFOLD RACK
• Type of Device: RACK TO WASHER
• Manufacturer (Section D): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 12844678
• MDR Text Key: 286133320
• Report Number: 9680353-2021-00044
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1