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 10/11/2018

Event Type  malfunction  

Manufacturer Narrative

A complaint was received stating that indicator dots were failing to transition to their signal color post sterilization.No lot number was available upon submitting the complaint to crosstex.Suspect product was available, however, returned product was limited to two (2) indicator dots which had already been processed.No unprocessed product was available for additional testing.Due to the unavailability of additional samples for testing, our investigation will be limited to a batch record review.A batch record review for the past two years shows no non-conformances on file or additional anomalies of note.All processed retains demonstrated color changes that were within specification.Additionally, a 1 year complaint history review was performed and no confirmed complaints are on file for this failure mode.This issue has been logged and will be monitored for recurrence.Should you experience additional complaints in relation to this failure mode, or should a lot number become available, a re-assessment will be completed.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.The complained product was not returned and the batch # was not provided.Due to the time frame, it was reasonable to assume that the product fell within the scope.

Event Description

It was reported there was an issue with the orange locks.The reporter indicated that the orange indicator locks for containers are coming out of sterilization with dots not changing color.It did not occur in surgery.No additional intervention needed.No serious injury or death.

• 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: 10002957
• MDR Text Key: 189345450
• Report Number: 2916714-2020-00135
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2018
• 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