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

Catalog Number	RMS32409
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Koru medical was made aware that during initial incoming inspection at a customer warehouse in japan, unidentified black debris/contaminant was found inside a sealed sterile needle set pouch involving rms32409/lot n.25b05n.Subsequently, the japanese warehouse personnel completed inspection on the remaining inventory.Upon completion, an additional sealed pouch was found to contain unidentified black debris/contaminant involving rms32414/lot n.87033.Mdr 1318360-2025-00021 is being filed for rms32414/lot n.87033.The customer provided photos of the pouches confirming the complaint.There was no patient involvement.A review of the device history record for rms32409/lot n.25b05n 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." 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
1318360-2025-00020 is being filed for rms32409/n.25b05n.1318360-2025-00021 is being filed for rms32414/lot n.87033.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: 23006863
• Report Number: 1318360-2025-00020
• Device Sequence Number: 10559454
• Product Code: FPA
• UDI-Device Identifier: 00659443000629
• UDI-Public: 00659443000629
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2025

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
• Operator of Device: Other
• Device Catalogue Number: RMS32409
• Device Lot Number: N.25B05N
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 09/09/2025
• Date Device Manufactured: 03/13/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown