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 05/09/2023

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 a pin hole in the filter on may 09 2023.The adverse event is filed under aic reference (b)(4).

Manufacturer Narrative

Additional information d4: lot number added.D9: device returned to manufacturer.H6: codes updated.Investigation results: one (1) sample was returned to the manufacturing site for technical evaluation.Results of the investigation determined visually that the 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 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.Based on the investigation findings, the pin holes most likely resulted from aggressive phase change during sterilization.As a result, the reported failure could not be confirmed to be a manufacturing related issue.No other complaints of this nature were identified against the reported batch number.

• 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: 17001861
• MDR Text Key: 316385147
• Report Number: 2916714-2023-00062
• Device Sequence Number: 1
• Product Code: KCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193582
• 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: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• 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: 2303004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• 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