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

Model Number US751

Device Problem Material Puncture/Hole (1504)

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

Event Date 10/19/2023

Event Type  malfunction  

Event Description

It was reported to aesculap inc.That a round filters w/indicator (part# us751) was used with a sterilization container provided for use during a surgical procedure on october 19 2023.According to the complainant the or staff found small holes in the sterile container filters.Per the report the sets had to be resterilized resulting in a delay to the procedure.The adverse event is filed under aic reference (b)(4) 2916714-2023-00110 (b)(4) - us751) 2916714-2023-00111 (b)(4)- us751) 2916714-2023-00112 (b)(4) - us751) 2916714-2023-00113 (b)(4) - us751) 2916714-2023-00114 (b)(4) - us751) 2916714-2023-00115 (b)(4) - us751) 2916714-2023-00116 (b)(4) - us751).

Manufacturer Narrative

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

Manufacturer Narrative

Updated information: d9 device returned to manufacturer, h6 codes updated.The samples provided were returned to the manufacturing site for technical evaluation.Results of the investigation determined that there were no defects or damages observed on the returned product.The device quality and manufacturing history records (dhr) review found the device was manufactured according to specification.Inspections are documented in the production record, all reflecting passing results.Retain samples were found to be conforming, no issues found with any of the sample reviewed.Based on the investigation findings, the cause of the pin holes was unable to be determined.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
• 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: 18118244
• MDR Text Key: 328747536
• Report Number: 2916714-2023-00117
• 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: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• 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: 2211003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2023
• 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: Initial
• Patient Sequence Number: 1