MAUDE Adverse Event Report: QUEST MEDICAL, INC. Q2 EXTENSION SET 17 IN (43.2 CM); MICRON FILTER EXTENSION SET

Model Number	95902
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No patient complications were reported.No complaint sample has been received for investigation.Quest medical has completed investigation through interviews and analysis of device history records and no device problem was found.Quest will continue to monitor complaint trends.
Event or Problem Description
It was reported that the device allegedly leaked the drugs it was delivering on the patient during fluid delivery treatment allegedly causing minor injury to the patient.

• Brand Name: Q2 EXTENSION SET 17 IN (43.2 CM)
• Common Device Name: MICRON FILTER EXTENSION SET
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002 4211
• Manufacturer (Section G): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002 4211
• Manufacturer Contact: stephanie ajayi ; one allentown parkway; allen, TX 75002-4211 ; 9723326290
• MDR Report Key: 19107019
• Report Number: 1649914-2024-00003
• Device Sequence Number: 7681995
• Product Code: FPA
• UDI-Device Identifier: 00634624959026
• UDI-Public: 00634624959026
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151079
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 95902
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Hispanic