MAUDE Adverse Event Report: CONTRACT MANUFACTURER: SPS MEDICAL SUPPLY CORP ROUND FILTERS W/INDICATOR; STERILE TECHNOLOGY

Model Number US751

Device Problem Chemical Problem (2893)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2018

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 while preparing for surgery, the instrument container was opened and it was noted that the chemical filter in the bottom of the case had not completely changed color.The issue caused a brief delay of 10 minutes during preparation for a total knee operation.The filter usually changes color and is one of the indicators of sterility used during instrument processing.Additional information has been requested.

Manufacturer Narrative

Visual inspection of both processed and unprocessed filter confirm the complaint.While the color transition did occur, the signal color would not be acceptable per our release criteria.Feedback received from both production supervisor and production lead offered possible root causes such as poor laydown of indicator ink during the manufacturing process.Insufficient applied pressure of the pressure pf the printing plate during the manufactured process.Insufficient indicator ink within ink pan of the printing press.A batch review for the past two years shows no non-conformance on files or additional anomalies of note.All processed retains demonstrated color change that were within specification.Additionally, a 1 year complaint history review was performed on 12/24/2018 and no confirmed complaints are on file for this failure mode.Based on the inability to show correlation between the suspect's product's failure mode and internal documentation resulting from lack of a lot number, additional root causes may include; product near or at the end of shelf life.Storage conditions at the point of use resulting in compromise of chemical indicator.We are confident that this confirmed complaint is an isolated incident and is unlikely to recur.As no lot number could be provided, testing of factory retains could not be performed as a comparison against the testing of the suspect product and batch record/complaint review was limited to a 2 year review.A definitive root cause could not be established as a result.Crosstex will replace the case of suspect product with the most current manufactured lot.

• Brand Name: ROUND FILTERS W/INDICATOR
• Type of Device: STERILE TECHNOLOGY
• Manufacturer (Section D): CONTRACT MANUFACTURER: SPS MEDICAL SUPPLY CORP; 6789 w henrietta road; rush NY 14543
• MDR Report Key: 8122239
• MDR Text Key: 129042432
• Report Number: 2916714-2018-00034
• Device Sequence Number: 1
• Product Code: JOJ
• 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: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Distributor Facility Aware Date: 12/05/2018
• Date Manufacturer Received: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1