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

Model Number US751

Device Problem Material Discolored (1170)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/08/2019

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 filter during surgery.During preparation for a total joint procedure, the color indicator of the sterility filter caused concern.This occurred on one of the instrument containers.The malfunction did not cause harm to the patient.It contributed to a delay of 30-45 minutes in which the set was re-sterilized.

Manufacturer Narrative

Manufacturing site evaluation: product was returned to aid in the investigation.Lot information is currently unknown.Initial review of the returned samples presented the following details; chemical indicator ink was present on the filters, although applied inconsistently and of a lighter coating (thinner in laydown).Chemical indicators did show a transition in color where indicator ink was thicker and uniform.After completion of initial sample review, the samples were then placed into a tabletop steam sterilizer and processed to test for additional color change under controlled conditions.The testing did not result in any additional color change or transition.Testing could not be performed against factory retains due to lot number unavailability.Similarly, dhr review could not occur due to the unknown lot number.Complaint review for this failure mode did not indicate a systemic issue and suggests this failure was limited to the returned product.Current process controls for us751 manufacture include; in-process sampling occurring at 30-minute intervals.Sample testing utilizes tabletop steam sterilizers and monitors for ink laydown inconsistencies.Finished good testing in a simulated point of use environment (hospital sterilizer testing).Final review of retains and dhr by representatives of both operations and quality assurance.In conclusion the failure was a result of inconsistent chemical ink laydown, in which areas that did not receive an adequate amount of the chemical indicator did not transition as intended at the point of use.Inconsistencies in ink laydown may be attributed to in-process line clear failures or failure to adequately clean the ink rollers during regular intervals.This complaint is currently isolated and the failure mode will be monitored for recurrence through the crosstex complaint system and product risk management files.

• 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: 8633967
• MDR Text Key: 145916646
• Report Number: 2916714-2019-00022
• Device Sequence Number: 1
• Product Code: FRG
• 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: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• 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: 05/08/2019
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INSTRUMENT CONTAINER