MAUDE Adverse Event Report: STERILUCENT, INC. FLEXIBLE CYCLE PCD; BIOLOGICAL INDICATOR

Model Number PCD-F

Device Problem No Apparent Adverse Event (3189)

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

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

Reporting facility: (b)(6).Number of decontamination cycles at the time of the event: variable (10 mask load), no greater than 4 decontamination method/process: sterilucent hc 80tt hydrogen peroxide sterilizer flexible cycle brand/model of decontaminated product: 3m 8210, 8201+ event description: failure of biological indicator evaluation/investigation of the reported event: evaluation of parametric cycle data indicated all parameters where within normal acceptable ranges.Investigation of the bi determined lot exhibits tailing.Disposition of the load: dispositioned as a failed cycle; cycle count incremented for each respirator; respirators were repackaged and reprocessed.Affected facilities: (b)(6).

Event Description

The user facility reported a positive bi.This report is required under the terms of the eua.

• Brand Name: FLEXIBLE CYCLE PCD
• Type of Device: BIOLOGICAL INDICATOR
• Manufacturer (Section D): STERILUCENT, INC.; 1400 marshall street ne; minneapolis MN 55413
• Manufacturer (Section G): STERILUCENT, INC.; 1400 marshall street ne; minneapolis 55413
• Manufacturer Contact: peter kalkbrenner ; 1400 marshall street ne; minneapolis, MN 55413 ; 6127673253
• MDR Report Key: 11272059
• MDR Text Key: 255112915
• Report Number: 3011026564-2020-00001
• Device Sequence Number: 1
• Product Code: FRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192001
• 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: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2021
• Device Model Number: PCD-F
• Device Catalogue Number: SL291
• Device Lot Number: B200727A5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 02/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2020
• 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