MAUDE Adverse Event Report: A PLUS INTERNATIONAL; TOWEL OR BLUE 17X25IN N ST

Model Number OR-1725-BS

Device Problem Contamination (1120)

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

Event Date 11/16/2021

Event Type  malfunction  

Manufacturer Narrative

The blue or towel was contained inside a custom procedure kit manufactured by roi cps, llc.Roi cps, llc is not the manufacturer of the towels that were found to be linting by the end user.

Event Description

There was lint on the blue towels in custom pack.Lint was found on towels and wires used during the procedure.There was patient contact, but no harm to patient at this time.

• Type of Device: TOWEL OR BLUE 17X25IN N ST
• Manufacturer (Section D): A PLUS INTERNATIONAL; 5138 eucalyptus ave; chino CA 91710
• Manufacturer (Section G): ROI CPS, LLC; 3000 east sawyer road; republic MO 65738
• Manufacturer Contact: cheyenne stewart ; 3000 east sawyer road; republic, MO 65738 ; 4176473205
• MDR Report Key: 12901392
• MDR Text Key: 284996517
• Report Number: 3014527682-2021-00021
• Device Sequence Number: 1
• Product Code: FRL
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OR-1725-BS
• Device Catalogue Number: OR-1725-BS
• Device Lot Number: F94699
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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