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

Catalog Number	200-IVRB201
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that the needle is exposed.No other 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: 23605674
• Report Number: 1451040-2025-00108
• Device Sequence Number: 15767826
• Product Code: QOI
• UDI-Device Identifier: 10612479267968
• UDI-Public: 10612479267968
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/20/2025
• Report Date (Section F): 11/20/2025

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: 40933, 40918, 40912, 50311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/31/2025
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2025
• 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: 11/20/2025