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 04/25/2023

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 observed to have pin holes in the filters on (b)(6) 2023.The malfunction is filed under aic reference (b)(4).

Manufacturer Narrative

Additional information: d4 (lot number).Updated information: d9 (device returned to manufacturer) h3 (device evaluated by manufacturer) h6 (codes updated).Results of the investigation determined there were no manufacturer defects present on the product.Based on the investigation findings, the pin holes resulted due to aggressive phase changes during sterilization.Aggressive phase changes in the sterilization cycle can cause repeated stress of the filter material against the metal case tray filter.Repeated stress has the potential to affect the filter material and compromise the sterile barrier.The device history records (dhr) were not able to be reviewed as no lot number was made available.However, 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.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

Investigation complete.

• 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: 16890757
• MDR Text Key: 314829482
• Report Number: 2916714-2023-00055
• 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: 10/24/2023

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 Model Number: US751
• Device Catalogue Number: US751
• Device Lot Number: 2303002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2023
• 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