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

Model Number	US994
Medical Device Problem Codes	Material Puncture/Hole (1504); Residue After Decontamination (2325)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: as advised, we will inspect and continue to reject the sterilization filters (us994) not only for the micro holes we are finding but now for the new imperfection, the black ink line.
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
This report has been identified as b.Braun medical internal report number (b)(4).Investigation results: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.Batch history review: the device history records (dhr) were not able to be reviewed as no lot number was made available.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.Conclusion and measures / preventative measures: a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4) (xc 100039331).Additional information: d suspected medical device information updated d9 device returned to manufacturer results of the investigation confirmed that micro-holes were observed in the filters.The device quality and manufacturing history records (dhr) review found the device was manufactured according to specification.Retain samples have been reviewed, and the potential for micro-holes have been identified.No black lines were observed on the samples.Based on the investigation findings, while the defect is confirmed product is meeting specification.The raw material supplier is an 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.The manufacturing site is aware of this issue and has entered this complaint into our trending report.

• 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: 22118592
• Report Number: 2916714-2025-00024
• Device Sequence Number: 4172174
• Product Code: KCT
• UDI-Device Identifier: 04046964930812
• UDI-Public: (01)04046964930812(10)2503006
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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,Followup
• Report Date (Section B): 08/29/2025

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: US994
• Device Catalogue Number: US994
• Device Lot Number: 2503006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 07/10/2025; 08/29/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown