MAUDE Adverse Event Report: QUEST MEDICAL, INC. PRECISION DELIVERY IV ADMINISTRATION 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	12/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Quest has not yet received the suspect device from st.Joseph's hospital.A review of the device history record revealed no quality or manufacturing concerns for the lot noted.Quest will file a supplemental report at the conclusion of the investigation.
Event or Problem Description
It was reported to quest medical of an alleged issue with a precision delivery iv set.The report stated that the set had a lipid line leak at the junction, just prior to the filter.No patient complications were reported.
Additional Manufacturer Narrative
Quest received the suspect sample for investigation.It was noted that the sets were being used for lipid infusion.The lipid infusion was stopped intermittently, but the filter line was not flushed.The root cause was determined to be leaking due to lipid occlusion of the filter in the line.Quest will continue to monitor this complaint trend.Quest has concluded its investigation.

• Brand Name: PRECISION DELIVERY IV ADMINISTRATION SET
• Common Device Name: IV 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: 16199458
• Report Number: 1649914-2023-00006
• Device Sequence Number: 4173749
• 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,Followup
• Report Date (Section B): 04/24/2023

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: 08/17/2025
• Device Model Number: PDV60FA
• Device Lot Number: 66994
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• 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