MAUDE Adverse Event Report: HARSORIA HEALTHCARE MCKESSON BRANDS; CATHETER, IV SFTY SLIDING STR BLU 22GX1"

Catalog Number	200-IVS221
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Unspecified Vascular Problem (4441)
Date of Event	02/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the customer that a patient was administered the iv catheter, but upon removal, it was discovered that the end plastic catheter sheath had detached from the hub.It was confirmed that the catheter remained lodged in the patient's arm.Vascular surgical intervention was required to remove it.
Additional Manufacturer Narrative
Based on the product sample received from the reported incident, it has been confirmed that the item did not originate from the supplier initially identified.The correct manufacturer has been subsequently identified and notified.The correct manufacturer is the importer of the product.

• Brand Name: MCKESSON BRANDS
• Common Device Name: CATHETER, IV SFTY SLIDING STR BLU 22GX1"
• Manufacturer (Section D): HARSORIA HEALTHCARE; 110-111 phase iv; udyog vihar sector 18; gurugram, haryana 12201 5; IN 122015
• MDR Report Key: 22229406
• Report Number: 1451040-2025-00043
• Device Sequence Number: 15671193
• Product Code: QOI
• UDI-Device Identifier: 10612479267548
• UDI-Public: 10612479267548
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2025
• Report Date (Section F): 07/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 200-IVS221
• Device Lot Number: 99818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/10/2025
• Device Age: 12 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/22/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 07/22/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/22/2025