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)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that the needle is still retracting but the needle still hangs out.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: 22646698
• Report Number: 3003674698-2025-00925
• Device Sequence Number: 20984933
• Product Code: QOI
• UDI-Device Identifier: 10612479268026
• UDI-Public: 10612479268026
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/29/2025

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-IVRB221
• Device Lot Number: 40901/0532
• 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: 07/29/2025
• Date Device Manufactured: 09/23/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown