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 Type  malfunction  

Manufacturer Narrative

Dots are from lot 570185-01 and samples were returned for further analysis.Upon initial inspection, no abnormalities could be noted with the dots.A 3m lead check test was utilized on a sample of the dots to confirm that these dots were manufactured with lead-based ink.Dots from lots 1508 - 1605 were manufactured with a different formulation, non-lead based, and had similar reports of color reversion.Upon confirmation of the lead based formulation a sampling of 30 dots were subjected to a simulated point of use study using a standard sterilization cycle of 270f for 4-minute cycles and a 15-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.Results show that dots exhibited fading, but no initial color of blue could be noted, final results as follows: of the sampling, no reversion was observed and this failure mode could not be replicated.As this was commonly reported for the unleaded dots, it is very possible that dots have become mixed at point of use.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 that indicator dots black turning to blue on the shelf a couple going back to november.Discovered in sterile processing.No patient harm reported.No surgical delay reported.

• 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: 9973417
• MDR Text Key: 189445261
• Report Number: 2916714-2020-00103
• 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: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: US906
• Device Catalogue Number: US906
• Device Lot Number: 570185-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2017
• Initial Date FDA Received: 04/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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