MAUDE Adverse Event Report: QUEST MEDICAL, INC. 10 IN. Q2 MULTIPORT MANIFOLD IV SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	9520
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to quest medical by progressive medical of an alleged issue with product code 9520.The report stated that the ports were cracking and leaking when opened.It was confirmed that there was no patient injury.
Additional Manufacturer Narrative
Quest medical received the suspect device on 2/10/2023.The complaint condition was confirmed.The port was detached from the manifold.The suspected root cause is weak weld of the port.Quest will continue to monitor and trend this complaint conditon.Quest has concluded its investigation.

• Brand Name: 10 IN. Q2 MULTIPORT MANIFOLD IV 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: brian hedden ; 1 allentown parkway; allen, TX 75002 ; 9723326311
• MDR Report Key: 16524723
• Report Number: 1649914-2023-00011
• Device Sequence Number: 17785034
• Product Code: FPA
• UDI-Device Identifier: 00634624952003
• UDI-Public: 00634624952003
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/10/2023

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: 9520
• Device Catalogue Number: 9520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 03/10/2023
• 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