MAUDE Adverse Event Report: AESCULAP INC. ROUND FILTER POLYPROPYLENE; DISPOSABLES CONTAINER SYSTEM

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	10/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to aesculap inc.That a round filter polypropylene (part number md344) was used during an operating room aseptic presentation on (b)(6) 2024.According to the complainant the operating room rejected the tray because there was a rip next tot, he hole where the retention pin goes in.Reportedly the back table was rejected due to contamination from the filter.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: the sample provided was sent to the manufacturing site for evaluation and the results of the investigation confirmed that there was a small tear around the center hole.The device quality and manufacturing history records (dhr) review found the device was manufactured according to specification.Retain samples were reviewed and no damages or discrepancies were observed.Based on the investigation findings, the defect is due to improper line clearance, the operator is to perform line clearance at start up to clear out any non-conforming material.This was not done effectively.The manufacturing site is aware of this issue and has entered this complaint into our trending report.The manufacturing supervisor has been made aware of this complaint.
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).Correction: section d4 udi number corrected.

• Brand Name: ROUND FILTER POLYPROPYLENE
• Common Device Name: DISPOSABLES CONTAINER SYSTEM
• Manufacturer (Section D): AESCULAP INC.; 3773 corporate parkway; center valley, pa 18034 ; GM 18034
• Manufacturer (Section G): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer Contact: elena reifenstein ; 3773 corporate parkway; center valley, PA 18034 ; 8334251464
• MDR Report Key: 20688971
• Report Number: 2916714-2024-00185
• Device Sequence Number: 7441222
• Product Code: KCT
• 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,Followup
• Report Date (Section B): 03/24/2026

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: 2407106
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 01/02/2025; 03/24/2026
• 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