MAUDE Adverse Event Report: HARSORIA HEALTHCARE MCKESSON BRANDS; CATH, IV SFTY STR PUSH BUTTON BC BLU 22GX1"

Catalog Number	200-IVRB221
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that the needle protruded when the device was turned upside down after retraction.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 BLU 22GX1"
• Manufacturer (Section D): HARSORIA HEALTHCARE; 110-111 phase iv; udyog vihar sector 18; gurugram, haryana 12201 5; IN 122015
• MDR Report Key: 22204539
• Report Number: 1451040-2025-00041
• Device Sequence Number: 20764131
• Product Code: QOI
• UDI-Device Identifier: 10612479268026
• UDI-Public: 10612479268026
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 06/13/2025
• Report Date (Section F): 06/13/2025

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-IVRB221
• Device Lot Number: 40901/0532 AND 40978/0591
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/29/2025
• Device Age: 12 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/13/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2025
• 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: 06/13/2025