MAUDE Adverse Event Report: ROI CPS, LLC REGARD; NEWBORN KIT-MERCY ADA

Model Number	830096005
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was identified as an internal finding that a bulk non-sterile needle was added to a custom procedure kit that is not sterilized prior to use.The needle was added to a kit that contains commodity items that are used after delivery for infant care.The needle is required to be sterile for use.The kits were distributed to 1 distribution center, were then returned to our firm, and were not further shipped to user facilities or used on patients.

• Brand Name: REGARD
• Common Device Name: NEWBORN KIT-MERCY ADA
• 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: 12848934
• Report Number: 3014527682-2021-00020
• Device Sequence Number: 4452188
• Product Code: MLS
• UDI-Device Identifier: 10194717112938
• UDI-Public: 10194717112938
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 11/19/2021

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
• Operator of Device: Other
• Device Expiration Date: 04/17/2023
• Device Model Number: 830096005
• Device Catalogue Number: 830096005
• Device Lot Number: 90074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3014527682-11-17-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown