MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries, Inc.; IV START KIT

Model Number	DYNDV1938
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a female undergoing an magnetic resonance imaging (mri) procedure had a device placed in the left antecubital (a/c) fossa.The patient was prepped for the procedure and upon walking into the room to begin injection of contrast material the tech noticed that the hub that should have been sealed on the device had come undone while the tech was in the control room setting up for the exam.The patient bled on the table and the floor (total amount of blood loss unknown).The tech was able to clean up the patient, place a new catheter and complete the procedure as ordered without further incident.The device was discarded and is not available to be returned for evaluation.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the hub came undone while connected to the patient prior to starting the contrast and the patient bled on the table and the floor (total amount of blood loss unknown).

• Brand Name: Medline Industries, Inc.
• Common Device Name: IV START KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 13090636
• Report Number: 1417592-2021-00229
• Device Sequence Number: 5711503
• Product Code: MCY
• UDI-Device Identifier: 10889942117291
• UDI-Public: 10889942117291
• 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: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/27/2021

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 Model Number: DYNDV1938
• Device Catalogue Number: DYNDV1938H
• Device Lot Number: 21HBH646
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female