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

Catalog Number	RMS22409
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Koru medical became aware that, during initial incoming inspection at a customer warehouse in japan, unidentified black debris or contamination was found inside eight sealed high-flo needle set pouches and one sealed precision flow rate tubing pouch.Additionally, two pouches from high-flo needle set rms12414/lot n.86873 were found to be damaged, potentially compromising the sterile barrier.Medical device reports (mdrs) are being filed for each affected device malfunction and lot.Mdr is being filed due to contamination of four pouches associated with high-flo needle set rms22409/lot n.25d32n.Mdr 1318360-2026-00010 is being filed due to contamination of one pouch associated with high-flo needle set rms12414/lot n.86873.Mdr 1318360-2026-00011 is being filed due to delivery of (potentially) unsterile products of two pouches associated with high-flo needle set rms12414/n.86873.Mdr 1318360-2026-00012 is being filed due to contamination of one pouch associated with high-flo needle set rms22414/n.86872.Mdr 1318360-2026-00013 is being filed due to contamination of one pouch associated with precision flow rate tubing fext/t.87065.Mdr 1318360-2026-00014 is being filed due to contamination of two pouches associated with high-flo needle set rms32409/n.25f49n.The customer provided photos of the pouches confirming the complaint.There was no patient involvement.A return material authorization was created to return all affected pouches to koru medical.A review of the device history record for high-flo needle set rms22409/lot n.25d32n 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.
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: 24928041
• Report Number: 1318360-2026-00009
• Device Sequence Number: 18809316
• Product Code: FPA
• UDI-Device Identifier: 00659443000582
• UDI-Public: 00659443000582
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/20/2026

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 Catalogue Number: RMS22409
• Device Lot Number: N.25D32N
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/20/2026
• Date Device Manufactured: 06/23/2025
• 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