MAUDE Adverse Event Report: ALBERT BROWNE LTD. CELERITY HP CHEMICAL INDICATOR

Lot Number 037227

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2021

Event Type  malfunction  

Event Description

The user facility reported that the celerity indicator dot is coming off and sticking to the blue wrap after the product had gone through sterilization cycle delaying a patient procedure.

Manufacturer Narrative

The celerity hp chemical indicator is used to distinguish between a processed and unprocessed device.When an operator removes an indicator from the sterilizer following a cycle, they should confirm the indicator spot changes from magenta to orange/yellow as this indicates the device has been exposed to a v-pro max sterilizer cycle.Based on the description of the event, it is likely that the reported event is attributed to excess moisture from not properly drying instruments or during handling of the indicator prior to processing.Excess moisture may reduce the adhesion of the chemical indicator spot from the celerity hp chemical indicator.The v-pro max sterilizer operator manual states (a-1), "dry all items thoroughly.Ensure all moisture is removed from all internal parts (including lumens)." steris inspected the retains of the lot number and confirmed there was no evidence of damage.Additionally, the dhr was reviewed and no abnormalities were found.No additional issues have been reported.

• Brand Name: CELERITY HP CHEMICAL INDICATOR
• Type of Device: CELERITY HP CHEMICAL INDICATOR
• Manufacturer (Section D): ALBERT BROWNE LTD.; chancery house190 waterside rd; hamilton industrial park; leicester, LE5 1 QZ; UK LE5 1QZ
• Manufacturer (Section G): ALBERT BROWNE LTD.; chancery house 190 waterside; hamilton industrial park; leicester, LE5 1 QZ; UK LE5 1QZ
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 13903078
• MDR Text Key: 296133809
• Report Number: 8021896-2022-00001
• Device Sequence Number: 1
• Product Code: JOJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 037227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1