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

Sample dots were provided for each lot on attached spreadsheet.A sample from each lot provided was tested with a 3m lead check to confirm these dots were manufactured with lead-based ink.In addition, a 130 dots were subjected to a standard sterilization process of 270ºf for 4-minute cycle 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 subject to a 7-day light study in which they were exposed to both artificial and natural light sources for 24 hours over a day period.The results showed some fading of the dots, but not reversion back to the initial color blue.Crosstex could not replicate the reversion of the dots back to blue.It is important to note that despite the occurrence of fading after sterilization, this product operates as intended.The sterilization dots are used as proof of exposure to steam not sterility.The process indicator cards are a type 1 medical device and it is important to note that the degree of color transition does not reflect more or less exposure.Any color transition to the signal color will serve as proof of sterilant exposure.In some instances, steam over-saturation or "wet steam" can cause the ink to bleed.Over-saturation is often the result of putting too much strain on the generators used to create steam and frequently occurs in facilities that utilize a shared steam source (ie; steam is shared with other departments such as dietary, linen, and sterilization).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 the indicator dots on the tags are turning back to blue after being exposed to steam.Discovered in central sterile core storage.No patient harm or 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: 9978089
• MDR Text Key: 191582066
• Report Number: 2916714-2020-00109
• 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 an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: US906
• Device Catalogue Number: US906
• Device Lot Number: 1702016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2017
• 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