MAUDE Adverse Event Report: AESCULAP INC. ROUND FILTERS W/INDICATOR

Model Number	US751
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complainant there were holes in the container filters.
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Updated information: d4 expiration date, lot information, primary unique identifier number (udi).H6 codes updated.Eleven (11) samples provided were returned to the manufacturing site for technical evaluation.Results of the investigation determined that there were no discrepancies noted, no holes were visible.The device quality and manufacturing history records (dhr) review found the device was manufactured according to specification.Based on the lot number provided with the returned sample- 1908010.The product expired on august 31 2022, based on dhr information.As a result, the reported failure could not be confirmed to be a manufacturing related issue.

• Brand Name: ROUND FILTERS W/INDICATOR
• Common Device Name: ROUND FILTERS W/INDICATOR
• 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: 20326128
• Report Number: 2916714-2024-00134
• Device Sequence Number: 15361203
• Product Code: KCT
• UDI-Device Identifier: 04038653473724
• UDI-Public: (01)04038653473724(17)220831(10)1908010
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 10/26/2024

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: 08/31/2022
• Device Model Number: US751
• Device Catalogue Number: US751
• Device Lot Number: AHYD11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 10/26/2024
• 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