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 09/02/2020

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

Supplier evaluation: the initial investigation was performed on lot 15031, which was noted to be expired; the product was manufactured in 2015 and has a 3-year shelf life.The product was later received and the investigation was re-opened.As noted, the lot number remained the same as above.The complaint had been that "color is changing back to blue".Product may not perform to specification if used when expired.Our investigation into the returned product confirmed the aforementioned.The sterilization tags attached to the processed locks returned have sterilization dates from august and (b)(6) 2020.In those months, the product would have been expired by several years.Moreover, a lead test was performed on an unprocessed sample returned.The lead test yielded no lead in the indicator ink.We changed to a lead-free ink formula around the time this batch was manufactured.However, due to ink reversion concerns, in (b)(6)2016, the ink was changed back to the original formula.That coupled with the fact that the product was expired upon use would explain why the product did not perform as intended.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: 10621098
• MDR Text Key: 209625767
• Report Number: 2916714-2020-00540
• 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: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• 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: 15031
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1