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

Model Number	RMS12409
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information becomes available, a supplemental report will be filed with the new information.
Event or Problem Description
Koru medical became aware of a report from a customer on 09-jun-2026 stating "one (1) unit of rms12409 (lot n.25j38n) has been observed with visual defect/possible contaminant on the tubing." on 09-jun-2026, koru quality control pulled all remaining inventory on this lot (14 pouches) which were visually inspected, and debris was found in 3 of the pouches.The customer provided photos of the pouch confirming the complaint.There was no patient involvement.A return material authorization was created to return the affected pouch to koru medical.A review of the device history record for high-flo needle set rms12409/lot n.25j38n was performed and no nonconformances or aberrant conditions were noted.High-flo needle sets are manufactured and sealed into their primary sterile barrier packaging in a controlled environment.In addition, high-flo needle sets are sterilized using gamma irradiation which is a highly penetrating and effective sterilization modality.Furthermore, validation of the sterilization method was performed using a conservative method (vdmax25) which provides a safety margin over alternate acceptable validation methods.The instructions for use for the high-flo needle sets states "subcutaneous needle sets are only sterile and non-pyrogenic if the packaging is unopened and undamaged.Do not use a needle set from an open or damaged package." a quality alert was issued by koru medical to make all relevant personnel aware of the complaint.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 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: 25717674
• Report Number: 1318360-2026-00015
• Device Sequence Number: 10618926
• Product Code: FPA
• UDI-Device Identifier: 00659443000544
• UDI-Public: 00659443000544
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2026

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 Model Number: RMS12409
• Device Lot Number: N.25J38N
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 07/06/2026
• Date Device Manufactured: 02/05/2026
• 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