MAUDE Adverse Event Report: SPS MEDICAL (CROSSTEX) STEAM STER LOCKS ORANGE; STERILE TECHNOLOGY

Model Number US906

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 02/02/2018

Event Type  malfunction  

Manufacturer Narrative

Samples from incident lot were returned for review and investigation.The samples provided were tested with a 3m lead check test to confirm the dots were manufactured with lead base ink.Upon confirmation of the lead based formulation a sampling of 40 dots were subjected to a simulated point of use study using a standard sterilization cycle of 270ºf for 4-minute cycles and a 20 minute dry time.Completion of testing yielded a 100% success rate in the dots transitioning to their signal color as intended.Dots were then subjected to a 7 day light study in which they were exposed to both artificial and natural light sources for 24 hours over the 7 day period.The results show that the dots exhibited some fading, but no initial color of blue.Based on the testing performed, crosstex was not able to replicate the failure mode.Crosstex is actively committed to providing quality products and client feedback is a tool that is utilized to implement process improvements and corrective actions.Note: a retrospective review of potential serious injury complaints was performed.This mdr was identified as a reportable malfunction as a result and filed as part of the review activities.

Event Description

It was reported there was an issue with the orange locks.The reporter indicated the set was set on the shelf for some time and it was noticed the us906 turned blue.The facility was uncertain if it was still ok to use or should it be replaced.No patient injury.No delay in surgery.

• Brand Name: STEAM STER LOCKS ORANGE
• Type of Device: STERILE TECHNOLOGY
• Manufacturer (Section D): SPS MEDICAL (CROSSTEX); 6789 w. henrietta road; rush, ny
• Manufacturer (Section G): AESCULAP INC; 3773 corporate parkway; center valley, pa
• Manufacturer Contact: lindsay chromiak ; 3773 corporate parkway; center valley, pa ; 2581946507
• MDR Report Key: 9978085
• MDR Text Key: 189353982
• Report Number: 2916714-2020-00118
• Device Sequence Number: 1
• Product Code: KCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K890759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1