MAUDE Adverse Event Report: QUEST MEDICAL, INC. PRECISION DELIVERY IV ADMINISTRATION SET; IV ADMINSTRATION SET

Model Number	PDV60FA
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to quest medical by (b)(6) of an alleged leaking iv administration set, requiring the set to be changed out.It was confirmed that there were no patient complications.
Additional Manufacturer Narrative
The suspect device was received by quest medical on (b)(6) 2022.Subsequent investigation of the device confirmed the reported complaint condition, as the device was found to be leaking at the distal end of the filter.Quest will continue to monitor complaint trends for this condition.

• Brand Name: PRECISION DELIVERY IV ADMINISTRATION SET
• Common Device Name: IV ADMINSTRATION 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: 16118203
• Report Number: 1649914-2023-00002
• Device Sequence Number: 5591054
• Product Code: FPA
• UDI-Device Identifier: 00634624922044
• UDI-Public: 00634624922044
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/06/2023

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 Model Number: PDV60FA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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