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

Model Number MD344

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2023

Event Type  malfunction  

Event Description

It was reported to aesculap inc.That a round filter polypropylene (part # md344) was used in a sterilization procedure on (b)(6)2023.According to the complainant the sterilization filter had numerous holes post sterilization.The malfunction is filed under aic reference (b)(4).

Manufacturer Narrative

Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Manufacturer Narrative

Investigation results: the hole found on the returned filter is consistent with aggressive cycle phase changes where the filter material was forced against the case tray's mesh screen repeatedly, resulting in the filter material being compromised where it was pushed thru the mesh, creating the hole.High temperature at extended cycle timing or left in the sterilizer while remaining at temperature may have caused the burned/ melted areas against the hot metal found on the mesh filter.The complaints database was reviewed with no other similar complaints found.The retain samples were not found to have any issues with the integrity of the product.Most likely cause for the reported event is from aggressive sterilizer cycle phase changes.The repeated stress of the filter against the mesh can result in holes in the filter material.The device history records (dhr) were reviewed for the available lot number; the device was found to be within specification at the time of production.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.

• Brand Name: ROUND FILTER POLYPROPYLENE
• Type of Device: 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: jonathan severino ; 3773 corporate parkway; center valley, PA 18034 ; 4847197287
• MDR Report Key: 16890999
• MDR Text Key: 314785370
• Report Number: 2916714-2023-00056
• Device Sequence Number: 1
• Product Code: KCT
• UDI-Device Identifier: 04522281506812
• UDI-Public: 4522281506812
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: MD344
• Device Catalogue Number: MD344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1