MAUDE Adverse Event Report: KORU MEDICAL SYSTEMS HIGH-FLO SUBCUTANEOUS SAFETY NEEDLE SETS

Model Number	RMS52609
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 1318360-2024-00008 is being filed for nurse #1, needle stick/puncture report.Mdr 1318360-2024-00009 is being filed for nurse #2, needle stick/puncture report.Mdr 1318360-2024-00010 is being filed for nurse #2, potential needle stick/puncture report.If additional information becomes available, a supplemental report will be filed with the new information.
Event or Problem Description
Koru medical became aware of 2 needle stick reports involving koru high flo subcutaneous safety needle sets.In both cases, the needle sets had been used on patients.Mdr 1318360-2024-00008 is being filed for nurse #1, needle stick/puncture report.Additional information was received for nurse#2 on (b)(6) 2024 stating the nurse removed the infusion needles from the patient and each needle was snapped shut upon removal (heard the snap).While disposing of the infusion set, one of the needles opened up and the nurse was punctured on the right index finger.The date of occurrence for this event is (b)(6) 2024.Mdr 1318360-2024-00009 is being filed for the first occurrence involving nurse #2.While teaching the patient the following day ((b)(6) 2024), all needle wings audibly snapped shut and one reopened after removal and snapping.A needle stick did not occur in this case.This mdr is being filed for the second occurrence with nurse #2.The nurse was wearing ppe (gloves) at the time the events occurred.The nurse followed the company's protocol for reporting, evaluation, etc.No adverse event outcomes were reported to have occurred.The initial reporter did not provide any identifying information for the nurse due to confidentiality.The lot number for the needle set involved in the events was reported as lot n.24e27n.Koru medical is currently investigating this event.This event meets the requirements for fda reportability; however, submission of this report does not constitute an admission that medical personnel, user facility, importer, manufacturer or product caused or contributed to the event.

• Brand Name: HIGH-FLO SUBCUTANEOUS SAFETY NEEDLE SETS
• Common Device Name: HIGH-FLO SUBCUTANEOUS SAFETY NEEDLE SETS
• Manufacturer (Section D): KORU MEDICAL SYSTEMS; 100 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): KORU MEDICAL SYSTEMS; 100 corporate drive; mahwah NJ 07430
• Manufacturer Contact: kayla kerschus ; 100 corporate drive; mahwah 07430 ; 8454692042
• MDR Report Key: 20528469
• Report Number: 1318360-2024-00010
• Device Sequence Number: 13037900
• Product Code: FPA
• UDI-Device Identifier: 00659443000452
• UDI-Public: 00659443000452
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K122404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/24/2024

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: Health Professional
• Device Model Number: RMS52609
• Device Lot Number: N.24E27N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown