MAUDE Adverse Event Report: HARSORIA HEALTHCARE MCKESSON; CATH, IV SFTY WNG PUSH BUTTON BC PNK 20GX1IN

Catalog Number	200-IVRWB201
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer states that if you press the end of the catheter once retracted you can still feel the needle.

• Brand Name: MCKESSON
• Common Device Name: CATH, IV SFTY WNG PUSH BUTTON BC PNK 20GX1IN
• Manufacturer (Section D): HARSORIA HEALTHCARE; 110-111 phase iv; udyog vihar sector 18; gurugram, haryana 12201 5; IN 122015
• MDR Report Key: 23417015
• Report Number: 3003674698-2025-01129
• Device Sequence Number: 12994093
• Product Code: FOZ
• UDI-Device Identifier: 10612479268088
• UDI-Public: 10612479268088
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2025

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-IVRWB201
• Device Lot Number: 50672/0461
• 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: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown