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	02/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
According to the event description the customer found a small pin hole in the filter.
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).Additional information: d4 lot information updated.G4 510k number corrected.One (1) sample provided was sent to the manufacturing site for evaluation and the results of the investigation confirmed visually that there was a pinhole found on the sample.The device quality and manufacturing history records (dhr) review found the device was manufactured according to specification.A 100% inspection was done on the retention samples of 271 filters; 3 filters pinholes were found.The raw material supplier confirmed that a vision system and manual inspection are in place to recognize any perforation with the limit of detection being 7 square millimeters (mm).They also confirmed they engage in american association of medical instrumentation (aami) level 3 certification for the supplied spunbond meltblown.Spunbond (sms) material post-treatment.The manufacturing site is aware of this issue and has entered this complaint into our trending report.There are no similar complaints against the reported lot number with this error pattern.Based on the investigation findings, the root cause was unable to be determined at this time.

• 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: 21528175
• Report Number: 2916714-2025-00007
• Device Sequence Number: 18566041
• Product Code: KCT
• UDI-Device Identifier: 14522281506819
• UDI-Public: (01)14522281506819(10)2411105
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Administrator/Supervisor
• 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 Model Number: MD344
• Device Catalogue Number: MD344
• Device Lot Number: 2411105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/05/2025
• 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): 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