MAUDE Adverse Event Report: QUEST MEDICAL, INC. PRECISION DELIVERY IV SETS; INTRAVASCULAR ADMINISTRATION SETS

Lot Number	68689
Medical Device Problem Codes	Fluid/Blood Leak (1250); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to quest medical by st.Joseph's hospital and medical center of an alleged leak with pdtv05fa trifuse delivery sets.No patient complications were reported.
Additional Manufacturer Narrative
Quest medical has not yet completed its investigation of this device.A supplemental report will be filed at the conclusion of this investigation.Quest will continue to monitor complaint trends for this complaint condition.
Additional Manufacturer Narrative
Quest received the suspect device from (b)(6).After decontamination of the sample, testing of the device noted an occlusion in the filter.After clearing the occlusion, there were no other occlusions detected, indicating the occlusions were not a result of excessive solvent.The customer reported that the sets were changed out every 96 hours.Per the device ifu, it is recommended to change out the set every 72 hours.Additionally, it is noted that if the sets are utilized for lipid infusions, leaving solutions for this length of time can cause the lipid solution to warm and stop line patency, leading to occlusions.The root cause of this complaint was noted to be leaking due to occlusion of the set due to failure to swap the set out after 72 hours.Quest has concluded its investigation of this complaint condition.Quest will continue to monitor complaint trends.

• Brand Name: PRECISION DELIVERY IV SETS
• Common Device Name: INTRAVASCULAR ADMINISTRATION SETS
• 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: 17695407
• Report Number: 1649914-2023-00025
• Device Sequence Number: 2598871
• Product Code: FPA
• UDI-Device Identifier: 00634624921023
• UDI-Public: 00634624921023
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2023

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 Expiration Date: 02/27/2026
• Device Lot Number: 68689
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2023
• 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