MAUDE Adverse Event Report: QUEST MEDICAL INC PRECISION DELIVERY TRIFURCATED IV EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	PDT05DF
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A line change was done at [date redacted].Upon starting the fluids, it was discovered that there was a crack in the lipid filter tubing after the filter and at the hub of the luer lock.(not from the filter) it was leaking and blood was backing up in the iv tubing.It was replaced.Several hours later, the replaced lipid filter was found to be leaking once again.It was replaced also.No patient harm.

• Brand Name: PRECISION DELIVERY TRIFURCATED IV EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): QUEST MEDICAL INC; 1 allentown pkwy; allen TX 75002
• MDR Report Key: 19729301
• Report Number: 19729301
• Device Sequence Number: 8190759
• Product Code: FPA
• UDI-Device Identifier: 00634624621121
• UDI-Public: (01)00634624621121
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/24/2024
• Report Date (Section F): 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PDT05DF
• Device Lot Number: 10987
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 07/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 15 DA
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/24/2024