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

Model Number 9520

Device Problems Loss of or Failure to Bond (1068); Break (1069)

Patient Problems Arrhythmia (1721); Tachycardia (2095); Low Oxygen Saturation (2477); Increased Respiratory Rate (2486)

Event Date 03/08/2022

Event Type  malfunction  

Manufacturer Narrative

The device was received by quest medical and the complaint condition was confirmed.Quest is still pending the completion of the investigation and will file a supplemental report once the investigation has been concluded.

Event Description

Medwatch (b)(4) was received by quest medical from (b)(6) medical.The report stated that, during a case at the (b)(6) medical center, a patient began having decreased oxygen saturation and increased heart rate and respirations.It was noted that the purple 6-port "multi-port" fluid adapter allegedly had a broken blue port, open to air.

Manufacturer Narrative

Quest medical received the device for investigation.Investigation of the device confirmed the complaint condition that the port on the manifold had a missing cap.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 Description

Medwatch (b)(4) was received by quest medical from progressive medical.The report stated that, during a case at the (b)(6) medical center, a patient began having decreased oxygen saturation and increased heart rate and respirations.It was noted that the purple 6-port "multi-port" fluid adapter allegedly had a broken blue port, open to air.

• Brand Name: 10 IN. Q2 MULTIPORT MANIFOLD IV SET
• Type of Device: 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: 14046650
• MDR Text Key: 294198504
• Report Number: 1649914-2022-00005
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00634624952003
• UDI-Public: 00634624952003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9520
• Device Catalogue Number: 9520
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other