MAUDE Adverse Event Report: KORU MEDICAL SYSTEMS FREEDOM60 PRECISION FLOW RATE TUBING

Model Number	F2400
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2022
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
On (b)(6) 2022, koru medical was made aware of a report received from a clinical site in (b)(6) stating "something black was inside a pack of tube.It is a foreign substance.The pack of tube was quarantined not to be dispensed to patients." a picture of the pouch was included with the report confirming foreign matter inside the pouch.The affected lot is precision flow rate tubing set f2400/lot t.80388.A return material authorization was created for return of the pouch to koru medical for further evaluation.The product is pending return to koru medical at this time.An internal quality alert was issued by koru medical to notify appropriate departments 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: FREEDOM60 PRECISION FLOW RATE TUBING
• Common Device Name: PRECISION FLOW RATE TUBING
• 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: 15916320
• Report Number: 1318360-2022-00018
• Device Sequence Number: 11849022
• Product Code: FRN
• UDI-Device Identifier: 00659443000223
• UDI-Public: 00659443000223
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K933652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2022

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: Lay User/Patient
• Device Model Number: F2400
• Device Catalogue Number: F2400
• Device Lot Number: T.80388
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 12/05/2022
• 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