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

Model Number US906

Device Problem Defective Component (2292)

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

Event Date 07/30/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information or investigation results will be provided, if available.

Event Description

It was reported that there was an issue with orange indicator dot.According to the complaint description, the blue dot on the orange lock changed from blue to brown as expected during sterilization.Sometime later the indicator dot changed to white.There was no patient involvement.

Manufacturer Narrative

Investigation results: as a lot number, photos, or returned product was not received, a targeted investigation could not occur.The complaint database was reviewed.As chemical indicators may be sensitive to environmental conditions, we do receive the occasional complaint for them.The complaint database will continue to be monitored for reoccurrence.It is important that steam indicator chemical indicators are stored correctly to ensure the product performs as expected.The 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.

• 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: 12365509
• MDR Text Key: 268066007
• Report Number: 2916714-2021-00168
• Device Sequence Number: 1
• Product Code: KCT
• UDI-Device Identifier: 05055049091927
• UDI-Public: 5055049091927
• Combination Product (y/n): N
• PMA/PMN Number: K944864
• 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: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1