MAUDE Adverse Event Report: AESCULAP INC STEAM STER LOCKS ORANGE; PROCESS INDICATOR LOCK

Model Number US906

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site investigation is on-going.Contract manufacturer: (b)(4).Pma 510(k): k890764.

Event Description

Country of complaint: usa.Customer reported that following processing of steril containers it was observed that the orange locks dots are changing back to blue.The customer stated that this caused a delay in several surgeries because they had to reprocess sets again.

Manufacturer Narrative

A retrospective review of potential serious injury complaints was performed.This mdr was identified and filed as part of the review activities.The complained product was returned and batch # 563747-01 was identified, along with samples of other batch numbers.Investigation at supplier indicated that mixed lots at customer facility wass highly probable, and it was reasonable to assume that the product fell within the scope of the description noted below.Supplier: (b)(4).Actions taken: capa opened by aesculap inc.Corrective action: sps- in october 2016, a labeling change had been made to state that this product should be kept out of direct sunlight, away from heat sources, away from hydrogen peroxide, and other sterilants.Description: there were an increased number of complaints on the indicator dot labels reverting back to blue or not fully turning.The supplier was made aware of the complaints and various lots were investigated.During the investigation, ink manufacturing process was reviewed and verified.No changes, other than going to a lead-free ink were made in the process or to the raw materials associated with making this product.Additionally, a comprehensive review was conducted with the ink manufacturer on the chemical makeup of the ink.No changes were made or found.Lastly, multiple tests and studies were conducted in an attempt to determine the root cause of the issues being reported by customers.Conclusion: at this time the issues of reversion and inconsistent color change were able to be duplicated.Through testing it was found that both lead and lead-free indicator labels would be adversely affected by being exposed to hydrogen peroxide post-sterilization.In all test cases, a reversion would occur once the processed label was exposed to hydrogen peroxide.The lead-free indicator labels were adversely affected by the exposure to direct sunlight and hydrogen peroxide.In hydrogen peroxide exposure prior to sterilization, an inconsistent color change was experienced and led to a reversion over the course of testing.Additionally, exposure to direct sunlight has caused the indicator label to revert and fluorescent light has begun to fade these indicator labels.Lead indicator labels were not as sensitive to these exposure types but did show signs that these exposures affected the product.During pre-sterilization hydrogen peroxide exposure, it was found that the lead indicator labels displayed an inconsistent color change.Both direct sunlight and fluorescent light did not appear to adversely affect the product.Corrective action: see above.

• Brand Name: STEAM STER LOCKS ORANGE
• Type of Device: PROCESS INDICATOR LOCK
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley, pa
• MDR Report Key: 5824082
• MDR Text Key: 50512899
• Report Number: 2916714-2016-00642
• Device Sequence Number: 1
• Product Code: KCT
• 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
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: US906
• Device Catalogue Number: US906
• Distributor Facility Aware Date: 06/21/2016
• Date Manufacturer Received: 11/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other