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

Model Number	9520
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received by quest medical and the complaint condition was confirmed.Quest is still pending completion of the investigation and will file a supplemental report once the investigation has been concluded.
Event or Problem Description
It was reported that the manifold for the multiport set was missing the top of one of the ports.It was confirmed that there were no patient complications.
Additional Manufacturer Narrative
Quest received the device for investigation.Analysis of the device confirmed the complaint condition reported.The root cause of the condition was inferred to be weak weld of the access port to the manifold.Quest will continue to monitor complaint trends for this complaint condition.Quest has concluded its investigation.
Event or Problem Description
It was reported that the manifold for the multiport set was missing the top of one of the ports.It was confirmed that there were no patient complications.

• 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: 14705359
• Report Number: 1649914-2022-00012
• Device Sequence Number: 2264856
• Product Code: FPA
• UDI-Device Identifier: 00634624952003
• UDI-Public: 00634624952003
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

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: 06/20/2024
• Device Model Number: 9520
• Device Catalogue Number: 9520
• Device Lot Number: 63133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2022
• Supplement Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2021
• 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