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 05/13/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.

Event Description

It was reported that there was an issue with the round filters.During preparation, it was discovered that the filter had an ink splatter.The facility became concerned and questioned the sterility of other devices, as well.Due to this malfunction, the hospital cancelled an unknown amount of procedures for (b)(6) 2019.There was no reported patient involvement nor surgery underway.Additional information was not provided.

Manufacturer Narrative

Multiple attempts had been made to receive the device.Supplier: crosstex/sps.Crosstex complaint #: (b)(4).Manufacturing site evaluation: crosstex received no samples, pictures or lot number to allowed for a targeted investigation.Crosstex monitors all complaints.When a trend is identified crosstex responds to resolve the problem.Upon review no trend was noted.This issue has been logged into the crosstex complaint system and will be monitored for recurrence.

• Brand Name: ROUND FILTERS W/INDICATOR
• Type of Device: STERILE TECHNOLOGY
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley, pa NY 14543
• MDR Report Key: 8664721
• MDR Text Key: 146950215
• Report Number: 2916714-2019-00025
• 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: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 05/13/2019
• Initial Date Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 06/03/2019
• Supplement Dates Manufacturer Received: 03/12/2020
• Supplement Dates FDA Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INSTRUMENT CONTAINERS