MAUDE Adverse Event Report: ROI CPS, LLC REGARD; C SECTION MOTHER-MERCY JOPLIN

Model Number LD00199P

Device Problems Delivered as Unsterile Product (1421); Packaging Problem (3007)

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

Event Date 06/03/2022

Event Type  malfunction  

Event Description

A non-sterile 10ml syringe was added to this kit as a sub item in place of the sterile version of the component.This kit is not sterilized prior to distribution, so the kit contents are required to be sterile prior to adding to the kit.The 10 ml syringe is required to be sterile for use, but was distributed to the direct account as non-sterile.

• Brand Name: REGARD
• Type of Device: C SECTION MOTHER-MERCY JOPLIN
• 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: 14735308
• MDR Text Key: 302272347
• Report Number: 3014527682-2022-00008
• Device Sequence Number: 1
• Product Code: OHM
• UDI-Device Identifier: 10194717110156
• UDI-Public: 10194717110156
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/17/2022

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: Other
• Device Expiration Date: 08/31/2023
• Device Model Number: LD00199P
• Device Catalogue Number: 830014016
• Device Lot Number: 92605
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/03/2022
• Initial Date FDA Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 301452768206172022008C
• Patient Sequence Number: 1