MAUDE Adverse Event Report: SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. INDICATOR DOT TO TAMPER EVIDENT LOCK; INDICATOR DOT TO TAMPER EVICENT LOCK

Model Number	US910
Medical Device Problem Code	Unexpected Color (4055)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is likely that the indicator dots turned white from being stored in direct lighting as stated in the instructions for use and on the outer packaging label of the indicator dots.The aesculap sterilcontainer system instructions for use states, "tamper evident lock us910 - low temperature external chemical indicators (cis) are particularly sensitive and must be stored in a controlled room temperature, away from alkaline chemicals, acids and sources of light prior to use.Do not use beyond the expiration date provided on the outside product packaging.Change of color prior to use in the sterilizer could indicate that these cis were exposed to too much light or high temperatures during storage.After being processed, low temperature tamper evident lock should be stored at a controlled room temperature away from alkaline chemicals, acids and sources of light.Indicators may turn white post-sterilization if not stored out of direct lighting." the outer packaging label of the indicator dots states, "caution: store at 20-25°c average, excursions 15-30°c allowed.Relative humidity range is 30-70%.Significant changes in storage conditions for prolonged periods can have an adverse effect on the product.Extreme storage conditions such as exposure to direct sunlight and/or storage on top of or near a heat source should be avoided.Store away from hydrogen peroxide and other sterilants." the lot number was not provided.A follow-up mdr will be submitted should additional information become available.
Event or Problem Description
The user facility reported that the indicator dots on their tamper evident locks turned white after being stored in the operating room for multiple weeks.A procedure delay was reported.No report of injury.
Additional Manufacturer Narrative
The lot number was provided by the user facility (2302003).The lot history record was reviewed, and no abnormalities were noted.There have been no other complaints associated with the lot number subject of the reported event.No additional information was obtained from the user facility in regard to the reported procedure delay.

• Brand Name: INDICATOR DOT TO TAMPER EVIDENT LOCK
• Common Device Name: INDICATOR DOT TO TAMPER EVICENT LOCK
• Manufacturer (Section D): SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL.; 6789 west henrietta rd; rush NY 14543
• Manufacturer (Section G): SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL.; 6789 west henrietta rd.; rush NY 14543
• Manufacturer Contact: daniel davy ; 6789 west henrietta rd.; rush, NY 14543 ; 4403927453
• MDR Report Key: 17655344
• Report Number: 1319130-2023-00010
• Device Sequence Number: 17720562
• Product Code: FRG
• UDI-Device Identifier: 04046964256967
• UDI-Public: 04046964256967
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2023

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: US910
• Device Lot Number: 2302003
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 10/20/2023
• Date Device Manufactured: 02/08/2023
• 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