MAUDE Adverse Event Report: AESCULAP INC. AESCULAP; STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES

Model Number	US751
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to aesculap inc.That a round filters w/indicator (part# us751) was used for during sterilization on (b)(6) 2025.According to the complainant there is a straight line going through the top of the filter that was seen post sterilization.Reportedly there was a delay of 5 minutes to the procedure as another set had to be pulled.The adverse event is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Investigation results: two (2) samples provided were sent to the manufacturing site for evaluation and the results of the investigation confirmed visually that there is a brown straight line on the filters.The device quality and manufacturing history records (dhr) review found the device was manufactured according to specification.Based on the investigation findings, the root cause is production related.Root cause- chemical indicator was located on the lift plate, when the chemical indicator dot was being placed on the filter, ink on the lift plate was placed on the filter in a line.The manufacturing site is aware of this issue and has entered this complaint into our trending report.There were no other reported similar events of this nature.

• Brand Name: AESCULAP
• Common Device Name: STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES
• Manufacturer (Section D): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer (Section G): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer Contact: jonathan severino ; 3773 corporate parkway; center valley, PA 18034 ; 4847197287
• MDR Report Key: 21324239
• Report Number: 2916714-2025-00001
• Device Sequence Number: 8485440
• Product Code: KCT
• UDI-Device Identifier: 04038653473731
• UDI-Public: (01)04038653473731(10)2409003
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K193582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2025

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: 2409003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 02/27/2025
• 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