MAUDE Adverse Event Report: AESCULAP INC ROUND FILTERS W/INDICATOR; FILTER WITH INDICATOR

Model Number US751

Device Problems Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that disposable filters used in sterilization container system had spots from the indicator ink all over them.They were noticed in both spd and the or.The or staff rejected the set.This did not effect any cases, as patients were not in the rooms.Surgery had not started.No patient injury.No delay in surgery.No additional intervention required.

Manufacturer Narrative

Multiple attempts had been made to obtain additional information and receive the device.Supplier: crosstex/sps.Manufacturing site evaluation: no samples were returned for evaluation in connection with the complaint.However, the malfunction has been confirmed through the (scar) - supplier corrective action report where similar defects with other complaints have been known to occur.Root cause - primary - ink viscosity was too high.Highly viscous ink becomes affixed to machinery and results in splatter.Secondary - no means of measuring viscosity nor a specification to measure against.Immediate actions - included an increase in quality control inspections, awareness training to operators was performed.Additionally, the press doctor blade was changed daily.Corrective action - a viscometer was acquired to measure ink viscosity.Subsequent data collection to determine optimal viscosity range.

• Brand Name: ROUND FILTERS W/INDICATOR
• Type of Device: FILTER WITH INDICATOR
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley, pa NY 14543
• MDR Report Key: 7916113
• MDR Text Key: 122009774
• Report Number: 2916714-2018-00021
• Device Sequence Number: 1
• Product Code: JOJ
• Combination Product (y/n): N
• PMA/PMN Number: K890763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: US751
• Device Catalogue Number: US751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Distributor Facility Aware Date: 09/11/2018
• Date Manufacturer Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1