MAUDE Adverse Event Report: AESCULAP, INC. ROUND FILTERS W/INDICATOR; STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES

Model Number US751

Device Problems Contamination (1120); Material Discolored (1170)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/20/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the round filters.There are some ink spots noted on the back of the filters before sterilization.It appeared to be the same color as the indicator dot.After the filters were sterilized there are more spots that appeared.There was no patient harm or surgery reported.

Manufacturer Narrative

Additional information - manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.The device history records (dhr) were reviewed for all available lot numbers; the devices were 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.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: ROUND FILTERS W/INDICATOR
• Type of Device: STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES
• Manufacturer (Section D): AESCULAP, INC.; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 8713688
• MDR Text Key: 148549261
• Report Number: 2916714-2019-00027
• Device Sequence Number: 1
• Product Code: KCT
• Combination Product (y/n): N
• PMA/PMN Number: K944864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• 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
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/22/2019
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1