MAUDE Adverse Event Report: QUEST MEDICAL, INC. PRECISION DELIVERY INFUSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	PDTV05F
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was received by quest medical, inc., on 07/26/2023.Investigation of the device confirmed the complaint condition of leaking.It was discovered that there was a leak at the male trifurcated luer.The root cause was determined to be insufficient solvent, resulting in the tubing not being inserted far enough into the bond pocket.Quest has concluded its investigation into this device.Quest will continue to monitor complaint trends for this complaint condition.
Event or Problem Description
It was reported to quest by (b)(6) hospital of an alleged leak with a trifurcated infusion line.It was confirmed that no patient complications were reported.

• Brand Name: PRECISION DELIVERY INFUSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): QUEST MEDICAL, INC.; 1 allentown parkway; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL, INC.; 1 allentown parkway; allen TX 75002
• Manufacturer Contact: brian hedden ; 1 allentown parkway; allen, TX 75002 ; 9723326311
• MDR Report Key: 17568912
• Report Number: 1649914-2023-00022
• Device Sequence Number: 17813389
• Product Code: FPA
• UDI-Device Identifier: 00634624621152
• UDI-Public: 00634624621152
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K202672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/23/2026
• Device Model Number: PDTV05F
• Device Lot Number: 68685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown