MAUDE Adverse Event Report: HARSORIA HEALTHCARE MCKESSON BRANDS; CATH, IV SFTY STR PUSH BUTTON BC PNK 20GX1"

Catalog Number	200-IVRB201
Medical Device Problem Codes	Leak/Splash (1354); Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that catheter appears to be occluded causing force to be used to push the plunger.This results in leakage due to the pressure used.The customer also reported that the needle doesn't retract after pushing the button.No information was received regarding any serious injury as a result of this product issue.

• Brand Name: MCKESSON BRANDS
• Common Device Name: CATH, IV SFTY STR PUSH BUTTON BC PNK 20GX1"
• Manufacturer (Section D): HARSORIA HEALTHCARE; 110-111 phase iv; udyog vihar sector 18; gurugram, haryana 12201 5; IN 122015
• MDR Report Key: 23719643
• Report Number: 1451040-2025-00116
• Device Sequence Number: 8420968
• Product Code: QOI
• UDI-Device Identifier: 10612479267968
• UDI-Public: 10612479267968
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2025
• Report Date (Section F): 12/04/2025

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: Health Professional
• Device Catalogue Number: 200-IVRB201
• Device Lot Number: 40576-0360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/21/2025
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/04/2025