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 08/24/2017

Event Type  malfunction  

Manufacturer Narrative

No lot number was available to report and no samples were available for additional testing during investigation.Photos were provided to illustrate the failure mode experienced at the point of use.Due to the lack of reportable information, the scope of the investigation will be limited to a 1 year batch record and complaint history review.Batch record reviews show that all lots manufactured during 2018 have met release criteria, with all testing results conforming and no anomalies of note.Color transitioning is dark in appearance and markedly different from unprocessed dots.Review of logged complaint history shows several complaints that were reported for an identical failure mode.No complaints on file have confirmed a lack of color transition.This issue has been logged and will be monitored for recurrence.Should additional information become available in relation to providing a sample or a lot number re-analysis will be made.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 indicator dots are not changing colors.Per the reporter, the facility are experiencing again the locks are not turning to black (pictures have been provided).These were done on the (b)(6).The autoclave parameters are good and the internal integrators from 3m have been changing as normal.It's all the aesculap products that are not changing well (the lot/load indicator card, the dot on the filters and locks).No patient injury; no prolonging of 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: 9973413
• MDR Text Key: 191580322
• Report Number: 2916714-2020-00106
• 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

• Date FDA Received: 04/17/2020
• 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: 08/30/2017
• 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