MAUDE Adverse Event Report: MEDSOURCE INTERNATIONAL LLC HENRY SCHEIN SAFETY IV CATHETER 22 G X 1.00; IV SAFETY CATHETER

Model Number	5702587
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer reports that no procedure was being done, but a 67 year old male was in pre-op scheduled for an endoscopic procedure.The office found that the iv was leaking fluid around the hub of the catheter where it was hooked up.The hub came off the patient without the plastic canula attached.The patient was then sent to the hospital for x-rays and an ultrasound.The patient was released same day with nothing being found.No device returned.Insufficient information to complete investigation.
Event or Problem Description
The cutomer reported that no procedure was being done but the patient, a 67 year old male was in pre-op, scheduled for an endoscopic procedure.The office found that the iv fluid was leaing around the hub of the catheter when it was hooked up.Then the hub came off of the patient without the plastic canula attached and could not be located.Therefor right after this was realized the patient was sent to the hospital for x-rays and an ultrasound.The patient was discharged the same day with nothing being found.

• Brand Name: HENRY SCHEIN SAFETY IV CATHETER 22 G X 1.00
• Common Device Name: IV SAFETY CATHETER
• Manufacturer (Section D): MEDSOURCE INTERNATIONAL LLC; 8600 shelby ct; suite 100; chanhassen MN 55317
• Manufacturer Contact: neeraj gupta ; 110-111, phase iv, udyog vihar; gurgaon, 12201-5 ; IN 122015
• MDR Report Key: 16868988
• Report Number: 3003674698-2023-00386
• Device Sequence Number: 5832624
• Product Code: FOZ
• UDI-Device Identifier: 00304040151990
• UDI-Public: 00304040151990
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2026
• Device Model Number: 5702587
• Device Lot Number: 10423-0430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male