MAUDE Adverse Event Report: AESCULAP INC. STERILCONTAINER S STER LOCKS PINK; STERILE TECHNOLOGY

Model Number US910

Device Problem Material Discolored (1170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2019

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 locks; they were not changing color correctly after sterilization of the container.Prior to surgery, when a patient was not yet in the operating room, the malfunction was noted.The procedure was delayed for about an hour.There was no patient harm.The central sterile processing (csp) staff pulled all other applicable instrument trays and checked for color of the indicators.New locks, stored in a black back in csp, had white dots instead of pink and were not used.Additional information was not provided.

Manufacturer Narrative

Below outlines the manufacturing process as well as the controls that are in place all work is dictated by applicable work instructions and inspection forms.All operators are trained to the procedures that they use.All operations including storage are performed in a temperature and humidity-controlled environment.The proprietary ink is manufactured in the ink room.Completed ink is inspected and tested for viscosity, ph, and appearance.Flood coated samples are exposed to a hydrogen peroxide cycle to confirm the correct signal color is seen.Quality verifies the dhr prior to product release.Using the proprietary ink and a flexographic press the ink is applied to the substrate material and dried.Production samples are subjected to an iso 11140-1 fail cycle and an iso 11140-1 pass cycle, and the operator visually inspect the material for defects.A 3/8" die is used to cut the dots.Slitters cut the edges so material is 1/8" from the edge.All rolls in progress are covered with black bags to block light from the ink.Gloves are worn when handling the product.Us 911 rolls are shrink wrapped and labelled.Product is not released for shipment until qa performs the final release inspection.When a complaint is received crosstex performs a device history record (dhr) and retain review when a product lot is provided.The review involves looking for any anomalies during production that might explain the failure.The retain review consists of looking at processed and unprocessed samples.Processed retains are reviewed for color reversion or an incomplete transition during acceptance testing.Unprocessed retains are exposed to the iso 11140-1 pass and fail cycles.Any discrepancies are noted for the complaint report.As of this date, crosstex has been unable to replicate ink failures without deviating from the product labeling or instructions for use.Complaints for hydrogen peroxide ink are common as the ink is sensitive, especially when exposed to certain types of light.Labeling is provided to guide the end user to avoid exposure to natural or uv lights, extreme heat sources, and residual sterilant.After usage, the indicators should not be retained as a permanent record of exposure but rather a photo of the indicator should be utilized due to the indicators' sensitivity to light.The following guidelines should be followed to prevent this failure mode from occurring; · avoid prolonged exposure to direct sunlight or uv lighting.· avoid storage at or near any hydrogen peroxide sterilizer.· avoid exposure to residual cleaning agents that may contain bleach, hydrogen peroxide, or other substances that could have an adverse impact to chemical indicators.Please note: to date, there have been no sentinel events associating the us910 sterilcontainer s ster locks pink device with a patient adverse event.Additionally, there is no information contained within the complaint record to suggest the occurrence of a serious injury or an adverse patient consequence.As no evidence exists to support a mdr reportable decision, the complaint has been reevaluated and deemed non-reportable.If further information is received, the complaint will be updated and reassessed for reportability.

• Brand Name: STERILCONTAINER S STER LOCKS PINK
• Type of Device: STERILE TECHNOLOGY
• Manufacturer (Section D): AESCULAP INC.; 615 lambert pointe drive; hazelwood MO 63042
• MDR Report Key: 8562637
• MDR Text Key: 144967199
• Report Number: 2916714-2019-00015
• Device Sequence Number: 1
• Product Code: FRG
• Combination Product (y/n): N
• PMA/PMN Number: K093493
• 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: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: US910
• Device Catalogue Number: US910
• Device Lot Number: 1806023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Distributor Facility Aware Date: 04/01/2019
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1