MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; IV ADMIN SET, 15DRP, 2 NF PORTS, 108"

Catalog Number	DYNDST1512
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, there have "multiple" occurrences where the "distal port begins leaking" within an "hour to a couple hours" of use.
Additional Manufacturer Narrative
According to the customer, there have "multiple" occurrences where the "distal port begins leaking" within an "hour to a couple hours" of use.The customer reported the tubing is leaking "lactated ringers and propofol".The customer reported they replaced the iv tubing after the reported incident occurred.The customer reported the "patients are fine".The customer reported no serious injury, medical intervention, or follow-up care related to the reported incident.No additional information is available at this time.Sample 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.

• Common Device Name: IV ADMIN SET, 15DRP, 2 NF PORTS, 108"
• 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: 18377826
• Report Number: 1417592-2023-00516
• Device Sequence Number: 7766850
• Product Code: FPA
• UDI-Device Identifier: 10884389975954
• UDI-Public: 10884389975954
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 12/21/2023

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 Catalogue Number: DYNDST1512
• Device Lot Number: 0332303A065
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/21/2023
• 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