MAUDE Adverse Event Report: AESCULAP INC STEAM STER LOCKS ORANGE; STERILE TECHNOLOGY

Model Number US906

Device Problem Material Integrity Problem (2978)

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

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

If additional information or investigation results become available, a supplemental report will be submitted.

Event Description

It was reported that there was an issue with a steam lock.It was noted that the steam indicators were changing color (back to blue) post sterilization.Additional information was not provided.

Manufacturer Narrative

Investigation results: the lot number which was provided does not correspond to a lot number in our system.As the lot number was no provided, the manufacturing batch record could not be reviewed nor could product retains.Two us-906 locks were returned by the customer.The indicator dots on both locks were dark grey upon inspection and appeared to have transitioned properly.As per iso 11140-1, the indicator demonstrated a visible change as specified by the manufacturer.The color appears to be slightly cloudy but not faded back to its original, pre-processed blue color.Complaints for steam indicator inks can occur if they are not stored correctly.Product should be stored at 20 - 25°c average, with a relative humidity range of 30 - 70%.Avoid exposure to direct sunlight and/or heat sources.Store away from sterilants.Labeling is provided to guide the end user to avoid exposure to natural or uv lights, extreme heat sources, and residual sterilants.The issue has been logged into the complaint system.

• Brand Name: STEAM STER LOCKS ORANGE
• Type of Device: STERILE TECHNOLOGY
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 11067230
• MDR Text Key: 224754318
• Report Number: 2916714-2020-00712
• Device Sequence Number: 1
• Product Code: KCT
• UDI-Device Identifier: 05055049091927
• UDI-Public: 5055049091927
• Combination Product (y/n): N
• PMA/PMN Number: K890759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: US906
• Device Catalogue Number: US906
• Device Lot Number: 597653-01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1