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

Model Number	MD344
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Event 6 it was reported to aesculap inc.That a round filter polypropylene (part # md344) was used during sterilization on (b)(6) 2024.According to the complainant there were holes present in the filter after sterilization.Reportedly there were eight (8) filters rejected.No patient complications were reported as a result of this event.The adverse event is filed under aic reference(b)(4).
Additional Manufacturer Narrative
Event 6 investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Event 6.Additional information: d9: device returned to manufacture.Two (2) samples were provided for technical evaluation.Results of the investigation determined visually that there were holes in the filters.The device quality and manufacturing history records (dhr) review found the device was manufactured according to specification.The raw material was evaluated without any initial discrepancies noted.Retention samples have been reviewed, no discrepancies noted.Based on the investigation findings, the hole's most likely resulted from the sterilization process, it does not appear to be related to the manufacturing process.As a result, the reported failure could not be confirmed to be a manufacturing related issue.

• Brand Name: ROUND FILTER POLYPROPYLENE
• 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: 21113679
• Report Number: 2916714-2024-00211
• Device Sequence Number: 12682606
• Product Code: KCT
• UDI-Device Identifier: 14522281506819
• UDI-Public: (01)14522281506819(17)271031(10)2410108
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K093493
• 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): 02/10/2025

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
• Device Model Number: MD344
• Device Catalogue Number: MD344
• Device Lot Number: 2410108
• 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: 12/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/10/2025
• 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