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)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the indicator dot on their round filters with indicator are not "uniformly dark brown" after processing.Procedure cancellations were reported as the devices were not utilized and were reprocessed.
Additional Manufacturer Narrative
The customer returned samples from the subject lot back for evaluation.During evaluation and testing of the returned round filters with indicator, the reported event was unable to be duplicated.No issues were noted, and the indicator dot turned dark brown as stated on the round filter.The instruction for use for the aesculap steril container 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." retain testing was conducted on the lot subject of the reported event and no issues were noted.The reported event was unable to be duplicated.A complaint review was completed and confirmed this to be an isolated event.No additional issues have been reported.

• 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: 18791195
• Report Number: 1319130-2024-00003
• Device Sequence Number: 12847920
• Product Code: KCT
• UDI-Device Identifier: 04038653473731
• UDI-Public: 04038653473731
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Device Lot Number: 2310002
• Was Device Available for Evaluation?: Yes
• 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): Yes
• 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