MAUDE Adverse Event Report: TERRAGENE S.A. STRYKER SCT40; CHEMICAL INDICATOR TAPE

Model Number	STRYKER SCT40
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An importer representative informed of opened two tapes and they turned green in the conference room of a hotel with no chemical presence and a minimal light exposure, as they were stored primarly in their packages.
Additional Manufacturer Narrative
Signs of possible instability of the product.Possible color change inside the original package since we do not have objective evidence about the time the tape was exposed to light.The retain sample did not show color change.However, there is a possibility of the device not meeting its specifications, which may cause the device to fail to perform its essential function and compromise the sterilization process monitoring effectiveness which could contribute to a serious injury.

• Brand Name: STRYKER SCT40
• Common Device Name: CHEMICAL INDICATOR TAPE
• Manufacturer (Section D): TERRAGENE S.A.; ruta nac. n° 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• Manufacturer (Section G): TERRAGENE S.A.; ruta nac. n° 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• Manufacturer Contact: hernando carrizo ; ruta nac. n° 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• MDR Report Key: 18397025
• Report Number: 3013145340-2023-00002
• Device Sequence Number: 2804793
• Product Code: JOJ
• UDI-Device Identifier: 07798164678205
• UDI-Public: 07798164678205
• Combination Product (Y/N): N
• PMA/510(K) Number: K191021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2023

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
• Operator of Device: Health Professional
• Device Model Number: STRYKER SCT40
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown