MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline; IV EXT SET,60",2.0ML, M/F LUERLOCK,CLAMP

Model Number	DYNDTN1603
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility lipids were noted to be leaking from cracked iv tubing.Per the facility the patient did not receive all of the lipid infusion as the incident was discovered after the iv was hung and the lipids were infusing.
Additional Manufacturer Narrative
According to the facility lipids were noted to be leaking from cracked iv tubing.Per the facility the patient did not receive all of the lipid infusion as the incident was discovered after the iv was hung and the lipids were infusing.Per the facility the tubing was confirmed to be secure prior to infusion.Per the facility there was no serious injury noted, medical intervention required, or follow up care needed after the reported incident.The facility stated that there was no harm to the patient.No additional information is available at this time.The sample was not 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.

• Brand Name: Medline
• Common Device Name: IV EXT SET,60",2.0ML, M/F LUERLOCK,CLAMP
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16870067
• Report Number: 1417592-2023-00199
• Device Sequence Number: 6090336
• Product Code: FPA
• UDI-Device Identifier: 10080196415076
• UDI-Public: 10080196415076
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/04/2023

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: DYNDTN1603
• Device Catalogue Number: DYNDTN1603
• Device Lot Number: 0332210A194
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 05/04/2023
• 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