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 03/04/2021

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 steam locks.It was noted that multiple steam indicators had not changed color.This was discovered in sterile processing department (spd); there was no patient involvement.Additional information was not provided.

Manufacturer Narrative

Evaluation: note that the lot number reported was 611146-01 however, that is not a valid lot number.As such the investigation was performed without lot number.Without a valid lot number we were unable to review a manufacturing batch record or evaluate product retains.We did however receive returned product and were able to investigate based on that.Returned product was received on 04/19/2021.Of the returned product received, 12 samples were processed.All of the samples transitioned.Note than one lock fell off during testing so the transition was slightly lighter than the remainder of the locks but it did still turn noticeably from the initial blue color.As the testing of the returned product did not yield any issues with the product transitioning, the most likely root cause is end user storage conditions or end user equipment.It is important that steam indicator cis 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: 11590274
• MDR Text Key: 262726502
• Report Number: 2916714-2021-00051
• 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: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• 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
• Device Lot Number: 611146-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1