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 Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2019

Event Type  malfunction  

Manufacturer Narrative

Crosstex (sap) recently received a complaint stating that indictor labels for the us906 product line, lot 1807004, are not transitioning upon completion of a full pre-vacuum sterilization cycle.Samples were forwarded for additional testing, along with photos, for the investigation.Suspect samples that were returned to crosstex were subjected a standard pre-vacuum sterilization cycle at 4 minutes exposure time with a drying time of 20 minutes.The cycle tape was reviewed to confirm successful and accurate results were achieved.No anomalies were noted, and all indicators transitioned as intended.Please see photos below for your reference.Review of batch records for lot 1807004 indicate that all testing and release criteria was met, with all factory retains transitioning as intended.While complaints for this failure mode have been logged, this complaint as it relates to the reported failure mode, cannot be confirmed.Since all release criteria for lot 1807004 has been has been met, no root cause can be determined at this time.This issue has been logged into the and will be monitored for recurrence.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 container lock indicators aren't turning dark when they run a full sterilizer cycle.This incident did not cause or contribute to serious injury or death or a delay in surgery.No additional intervention was needed.

• 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: 10002955
• MDR Text Key: 191837219
• Report Number: 2916714-2020-00129
• 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

• 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: 1807004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2019
• Initial Date FDA Received: 04/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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