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

Model Number	RMS32614
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 28-jan-2025 koru medical received 30 needle sets (3 boxes) of rms32614 (high-flo needle set 26 gauge needle sets - 3 needles - 14 mm) lot n.86417 from a customer under a return material authorization.There was no patient involvement.During quality control inspection of the 30 needle sets performed on 29-jan-2025, 2 needle sets were found contaminated with black debris and what appeared to be hair.Koru initiated an internal non-conformance report to investigate.In addition, an internal quality alert was initiated to inform internal personnel of the non-conformance.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.
Additional Manufacturer Narrative
If additional information becomes available, a supplemental report will be filed with the new information.

• Brand Name: HIGH-FLO SUBCUTANEOUS NEEDLE SETS
• Common Device Name: HIGH-FLO SUBCUTANEOUS 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: christine trefethen ; 100 corporate drive; mahwah, NJ 07430 ; 8456105572
• MDR Report Key: 21458437
• Report Number: 1318360-2025-00009
• Device Sequence Number: 15399040
• Product Code: FPA
• UDI-Device Identifier: 00659443000377
• UDI-Public: 00659443000377
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K211206
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/25/2025

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 Model Number: RMS32614
• Device Lot Number: N.86417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown