MAUDE Adverse Event Report: AESCULAP INC. ROUND FILTERS W/INDICATOR; DISPOSABLES CONTAINER SYSTEM

Model Number US751

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 05/16/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to aesculap inc.That a round filters w/indicator (part # us751) was used with a sterilization container provided for us during a surgical procedure on (b)(6) 2023.According to the complainant, while inspecting the contents of the tray after opening, pin holes were observed in the filter.No patient complications were reported as a result of the event.The malfunction is filed under aic reference (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: one (1) sample was returned to the manufacturing site for technical evaluation.Results of the investigation determined that there was a pin hole present on the filter.Direction of the puncture appears to be from the underside as if something pushed through from inside the tray.The device quality and manufacturing history records (dhr) review found the device was manufactured according to specification.There is the potential when the phase changes in the sterilization process are overly aggressive, and the filter material is wetted that it can result in small pinholes where the filter material is pressed against the mesh flange.No manufacturing related defect was identified.As a result, the reported failure could not be confirmed to be a manufacturing related issue.

• Brand Name: ROUND FILTERS W/INDICATOR
• 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: 17073490
• MDR Text Key: 316710893
• Report Number: 2916714-2023-00065
• Device Sequence Number: 1
• Product Code: KCT
• UDI-Device Identifier: 04038653473724
• UDI-Public: 4038653473724
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

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
• Device Operator: Health Professional
• Device Model Number: US751
• Device Catalogue Number: US751
• Device Lot Number: 2302006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2023
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: 05/17/2023
• Supplement Dates FDA Received: 01/30/2024
• 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: Initial
• Patient Sequence Number: 1