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

Catalog Number	B2-70072-F
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The damaged cases were requested to be return for further investigation.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 (b)(4) 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
05/29/2024, infutronix medical received a report from the customer that one of the cases/pouch had been physically damaged b2-70072-f.No report patient was involved.
Additional Manufacturer Narrative
Upon reassessment, the reported packaging issue: box physical damage failure mode has been determined to be non-reportable.The occurrence of the box being physically damaged represents a severity of 1: inconvenience or temporary discomfort.Our evaluation concluded that the event did not pose a risk to the health of patients, users, or bystanders.Furthermore, the report did not allege a serious injury or death, nor would a recurrence of the reported issue be expected to cause or contribute to a serious injury or death.Refer to complaint #: (b)(4).

• 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: 19554481
• Report Number: 3006575795-2024-00337
• Device Sequence Number: 6711102
• Product Code: FPA
• UDI-Device Identifier: 00814371020204
• UDI-Public: 00814371020204
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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: Lay User/Patient
• Device Catalogue Number: B2-70072-F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 03/25/2025
• 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 Sex: Unknown