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

Model Number US751

Device Problem Material Puncture/Hole (1504)

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

Event Date 03/11/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was an issue with the round filters. While preparing instrument packages prior to surgery, pin-size holes were found in the filters, which are sterility indicators. There was no patient harm or intervention required; however, a delay of up to 30 minutes was noted. Additional information was not available.

Manufacturer Narrative

Multiple attempts had been made to obtain additional information and 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: 8588741
• Report Number: 2916714-2019-00010
• 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: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: US751
• Device Catalogue Number: US751
• Was Device Available for Evaluation?: Yes

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 03/11/2019
• Event Location: No Information
• Date Manufacturer Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Treatment(s): INSTRUMENT CONTAINER.