MAUDE Adverse Event Report: QUEST MEDICAL, INC. Q2 LOW PRESSURE POWER INJECTION EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	95907
Medical Device Problem Codes	Fluid/Blood Leak (1250); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Quest medical has not yet received the affected device from avia vascular for investigation.Quest will file a supplemental report at the conclusion of the investigation.
Event or Problem Description
It was reported to quest medical by avia vascular of an alleged defect with product code 95907.The report indicated that a leak had occurred in the line.It was confirmed that there were no patient complications.
Additional Manufacturer Narrative
A representative from quest went to the customer's location to determine a possible root cause for the reported product failure.The representative was able to complete 4 cases with the customer's blood collection device with no issues.The root cause was determined to be a usage error.Quest has concluded the investigation.Quest will continue to monitor complaint trends for this complaint condition.

• Brand Name: Q2 LOW PRESSURE POWER INJECTION EXTENSION 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: daniel mckearan ; 1 allentown pkwy; allen, TX 75002 ; 9723326430
• MDR Report Key: 17490763
• Report Number: 1649914-2023-00021
• Device Sequence Number: 20790262
• Product Code: FPA
• UDI-Device Identifier: 00634624959071
• UDI-Public: 00634624959071
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K162804
• 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): 08/09/2023

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: 09/27/2025
• Device Model Number: 95907
• Device Lot Number: 67356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2023
• Supplement Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• 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