MAUDE Adverse Event Report: ROI CPS, LLC REGARD; OR DELIVERY PACK

Model Number LD00377N

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 08/22/2023

Event Type  malfunction  

Event Description

Holes and tears discovered in the vented bag and through the back table cover.Source of the tears is unknown.

Event Description

Holes and tears discovered in the vented.Source of the tears is unknown.

Manufacturer Narrative

The kits returned to our firm were reviewed and the customer problem statement was not confirmed.The damage to the returned kit as to the vented bag only and no the back table cover.

• Brand Name: REGARD
• Type of Device: OR DELIVERY PACK
• Manufacturer (Section D): ROI CPS, LLC; 3000 east sawyer road; republic MO 65738
• 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: 17664159
• MDR Text Key: 322430797
• Report Number: 3014527682-2023-00011
• Device Sequence Number: 1
• Product Code: MLS
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2024
• Device Model Number: LD00377N
• Device Catalogue Number: 800224014
• Device Lot Number: 95936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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