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

Model Number	DYNDV2013C
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported on (b)(6) 2023 "contrast was escaping the extension-t through the second port and once disconnected blood began to backflow from the port".It was reported that the rn was able to "locate rubber blue stopped that fit into microclave of the extension t on the floor".The customer reported no injury or medical intervention related to the incident, however the ct was not able to be performed.It was reported that the provider opted to treat the patient without imaging.A sample was requested to be returned for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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
Extension set leaked after contrast administration.

• 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: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17117347
• Report Number: 1417592-2023-00244
• Device Sequence Number: 6574201
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/13/2023

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
• Device Model Number: DYNDV2013C
• Device Catalogue Number: DYNDV2013C
• Device Lot Number: 23BBG394
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 06/13/2023
• 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