MAUDE Adverse Event Report: ROI CPS, LLC REGARD; ORTHO EXTREMITY PACK

Model Number OR00353L

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 10/05/2021

Event Type  malfunction  

Event Description

Tears/cuts in vented bag was identified prior to the kit being brought into the operating room.No patient contact, no harm to patient and no delay to case.Pack was discarded and a new one pulled from inventory.

• Brand Name: REGARD
• Type of Device: ORTHO EXTREMITY 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 ; 4176473170
• MDR Report Key: 12618748
• MDR Text Key: 278085646
• Report Number: 3014527682-2021-00017
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 10194717106654
• UDI-Public: 10194717106654
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2023
• Device Model Number: OR00353L
• Device Catalogue Number: 800200012
• Device Lot Number: 89182L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2021
• 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