MAUDE Adverse Event Report: INFUTRONIX, LLC ADMINISTRATION SET FOR AMBULATORY INFUSION PUMP; IV ADMISTRATION SET

Model Number	AX80075
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected bags were requested to be return for further investigation.They were received on 05/23/2024, investigation in process.This mdr will be reopened and updated in the event the affected bags involved or additional information becomes available.Historical records were reviewed.It was discovered that there were discrepancies in the test records.Ncr #2024-018 had been initiated to address the discrepancies.A capa has been opened in order to fully investigate and address the root cause of the reported event.Reference to complaint (b)(4).
Event or Problem Description
05/08/2024, infutronix medical received a report from the patient that the tubing had separated from the catheter.The patient stated that per the doctor's instructions they were directed to remove the catheter.Upon removing it, the patientt stated that the remaining therapy/medication was lost.No patient injury/harm reported.

• Brand Name: ADMINISTRATION SET FOR AMBULATORY INFUSION PUMP
• Common Device Name: IV ADMISTRATION SET
• Manufacturer (Section D): INFUTRONIX, LLC; 177 pine street; natick MA 01760
• Manufacturer (Section G): INFUTRONIX, LLC; 177 pine street; natick MA 01760
• Manufacturer Contact: frederick lee ; 177 pine street; natick, MA 01760 ; 5086502007
• MDR Report Key: 19479562
• Report Number: 3011581906-2024-00589
• Device Sequence Number: 11771274
• Product Code: FPA
• UDI-Device Identifier: 00817170020048
• UDI-Public: 00817170020048
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K130690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/06/2024

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: AX80075
• Device Catalogue Number: HS-002
• Device Lot Number: 2305030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female