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 08/10/2018

Event Type  malfunction  

Manufacturer Narrative

Crosstex (sps) received a complaint in which it was reported that us906 steam indicator dots (lots 1803008 and 580031-01) were failing to transition in color during sterilization.It was noted that there has been no patient injury and no surgical delay was reported.Review of production batch records associated with both the receipt testing of chemical indicator ink as well as testing of finished goods showed no non-conformances.Product operated as intended throughout the manufacturing and product release process.Upon receipt of the returned suspect product, testing of factory retains from lot 1803008 as well as samples from the returned product was conducted.Review of all samples processed showed that the product in both cases transitioned and performed as intended.Further review of complaints associated with lot 1803008 was performed with no verified complaints.This issue against lot 1803008 has been logged within the complaint system and will be monitored for recurrence.All complaints against this lot will be tested in similar fashion, and should a complaint be verified crosstex will re-evaluate the issue and reopen other associated complaints for additional investigation as applicable.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 color on the orange tags did not change during sterilization.This has happened with several locks from various lot numbers.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: 10002953
• MDR Text Key: 191835161
• Report Number: 2916714-2020-00131
• 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: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• 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: 1803008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2018
• 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