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

Model Number	US751
Medical Device Problem Codes	Material Puncture/Hole (1504); Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: event 4: customer is inspecting holes in filters when filter is reflecting sun and light in certain ways.Customer could not provide a lot number but gave 4 filter samples.One unused and 3 used.The filters around the word aesculap seem lighter under light in certain areas and customer circled the holes.One sample is from a 2023 filter.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow-up will be submitted when the investigation results become available.
Additional Manufacturer Narrative
The adverse event is filed under aic reference xc (b)(4).Corrected information: g4 510k number corrected.Event 4 four (4) samples provided were sent to the manufacturing site for evaluation and the results of the investigation confirmed the presence of pin sized holes in some areas.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 was unable to be determined.The raw material supplier is an international organization for standardization (iso) 13485 certified supplier for sterilization packaging and infection control material and tests each lot of this filter material for porosity, permeability, and water repellency.Retains have been reviewed, and the potential for microholes have been identified.

• Brand Name: AESCULAP
• Common Device Name: STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES
• Manufacturer (Section D): AESCULAP; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP INC; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: jonathan severino ; 3773 corporate parkway; center valley, PA 18034 ; 4847197287
• MDR Report Key: 22122312
• Report Number: 2916714-2025-00028
• Device Sequence Number: 4251293
• Product Code: KCT
• UDI-Device Identifier: 04038653473731
• UDI-Public: (01)04038653473731(17)260331(10)2303006
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K944864
• 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): 07/16/2025

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 Expiration Date: 03/31/2026
• Device Model Number: US751
• Device Catalogue Number: US751
• Device Lot Number: 2303006
• 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: 05/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown