MAUDE Adverse Event Report: SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. ROUND FILTERS WITH INDICATOR

Model Number	US751
Medical Device Problem Code	Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility sent back samples of the round filters with indicator for evaluation.The round filters with indicator were processed, and all samples evidenced passing results; the indicator dot changed fully in color.The reported event was unable to be duplicated.The instruction for use for the aesculap sterilcontainer system instructions for use states (pg.25), "after sterilization, the external indicator should change from the original indicator color to indicate exposure to sterilant.The post sterilization indicator color may vary and not be evenly shaded.Extreme storage conditions such as exposure to direct sunlight and/or storage on top of or near heat source should be avoided.Do not use if the indicator dot color has changed before being processed.Indicators may turn white post-sterilization if not stored out of direct lighting." as no issues were noted with the samples provided by the customer and the reported event could not be duplicated, a root cause could not be determined.No additional issues have been reported.
Event or Problem Description
The user facility reported that the filter indicator dot did not fully change in color.A procedure delay was reported as the devices were not utilized and were reprocessed.

• Brand Name: ROUND FILTERS WITH INDICATOR
• Common Device Name: INDICATOR
• 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: 18791167
• Report Number: 1319130-2024-00002
• Device Sequence Number: 8296535
• Product Code: KCT
• UDI-Device Identifier: 04038653473731
• UDI-Public: 04038653473731
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2024

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: US751
• Device Catalogue Number: US751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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