MAUDE Adverse Event Report: AESCULAP INC ROUND FILTERS W/INDICATOR; STERILE TECHNOLOGY

Model Number US751

Device Problem Material Discolored (1170)

Patient Problem No Patient Involvement (2645)

Event Date 04/22/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

There was an issue with the round filter with indicator dot.It was noted that color from the indicator dot had bled onto other parts of the filter.This was found after sterilization of an instrument set had occurred and while setting up for a procedure.The malfunction not cause a delay, but re-sterilization of the set was performed.

Manufacturer Narrative

B5- clarification: a supplier corrective action request (scar) was launched for ink splatters on the filter.In response to the scar, the manufacturer revealed that the ink splatter is due to the chemical indicator having too high a viscosity for the manufacturing equipment.The high viscosity ink becomes stuck to applicators, resulting in splatter throughout the process.The manufacturer has also stated that splatter ink is the same ink as the chemical indicator ink, and is not a contaminant nor a deficiency which affects the functionality of the product.The manufacturer has since planned to establish viscosity specifications that will minimize the occurrence of the splatter.The complaint is confirmed.

Event Description

Clarification was received: sales consultant confirmed that the indicator ink bleed appeared to worsen after the sterilization process; it was initially noted upon receipt of the devices in the mail, per the facility.

• Brand Name: ROUND FILTERS W/INDICATOR
• Type of Device: STERILE TECHNOLOGY
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 8629671
• MDR Text Key: 145769849
• Report Number: 2916714-2019-00020
• 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: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• 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: 04/23/2019
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INSTRUMENT CONTAINER; INSTRUMENT CONTAINER