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

Model Number	DYNDV2013C
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, the patient was receiving iv contrast "via power injector" for an "orbital ct scan" when the "2nd port on extension began to spew contrast".The customer reported the "patient did not cooperate with procedure after device failure".The customer reported the patient received "versed" prior to the ct and the medication wore off before the patient was able to get the ct and the "parents elected not to attempt another ct scan".According to the customer a "scout" image was obtained prior to contrast therefore the patient received "radiation without being able to complete full scan".Sample was requested for return evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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
According to the customer, the patient was receiving iv contrast "via power injector" for an "orbital ct scan" when the "2nd port on extension began to spew contrast".

• Brand Name: Medline Industries, Inc.
• Common Device Name: IV START KIT CEN HUB
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17148706
• Report Number: 1417592-2023-00247
• Device Sequence Number: 20288115
• Product Code: LRS
• UDI-Device Identifier: 10889942753505
• UDI-Public: 10889942753505
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2023

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 Model Number: DYNDV2013C
• Device Catalogue Number: DYNDV2013C
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown