MAUDE Adverse Event Report: CROSSTEX INTERNATIONAL AESCULAP; INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS

Model Number	MD347
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
User facility reported several of the sterile indicator tags for trays that go to the or (operating room) are very similar and easily confused.Leading to potential use of an unclean or not sterile tray for a sterile procedure.User facility did not provide any samples, batch numbers or pictures.

• Brand Name: AESCULAP
• Common Device Name: INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS
• Manufacturer (Section D): CROSSTEX INTERNATIONAL; 6789 west henrietta rd.; rush NY 14543
• Manufacturer (Section G): CROSSTEX INTERNATIONAL; 6789 west henrietta rd.; rush NY 14543
• Manufacturer Contact: stephanie wasielewski ; 6789 west henrietta rd.; rush, NY 14543 ; 8472574500
• MDR Report Key: 20782397
• Report Number: 1319130-2024-00007
• Device Sequence Number: 20096672
• Product Code: JOJ
• UDI-Device Identifier: 14522281000508
• UDI-Public: (01)14522281000508
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K890765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2024

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: MD347
• Device Catalogue Number: MD347
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 11/26/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown