MAUDE Adverse Event Report: AESCULAP INC. STERILCONTAINER S STER LOCKS PINK STERILE TECHNOLOGY

Model Number US910

Device Problem Material Discolored (1170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the locks; they were not changing color correctly after sterilization of the container. Prior to surgery, locks on an instrument set were noted as having turned to white instead of blue. There was a short delay (15 minutes) while sterilization cycles and monitoring records were checked to validate sterility. There was no patient harm. The central sterile processing (csp) staff confirmed that new locks were stored in a black bag to avoid light contamination. Additional information was not provided.

• Brand Name: STERILCONTAINER S STER LOCKS PINK
• Type of Device: STERILE TECHNOLOGY
• Manufacturer (Section D): AESCULAP INC.; 615 lambert pointe drive; hazelwood MO 63042
• Manufacturer (Section G): AESCULAP INC; 3773 corporate parkway; center valley, pa MO 63042
• Manufacturer Contact: lindsay chromiak ; 3773 corporate parkway; center valley, pa, MO 63042 ; 3145515988
• MDR Report Key: 8562635
• MDR Text Key: 143725609
• Report Number: 2916714-2019-00016
• Device Sequence Number: 1
• Product Code: FRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093493
• 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,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: US910
• Device Catalogue Number: US910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 04/03/2019
• Event Location: No Information
• Date Manufacturer Received: 06/08/2020
• 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