MAUDE Adverse Event Report: QUEST MEDICAL, INC. Q2 MULTIPORT EXTENSION SET - 10 INCH; INTRAVASCULAR ADMINISTRATION SET

Model Number 9520

Device Problem Gas/Air Leak (2946)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

No complaint sample has been received for investigation and no lot number was provided by the customer.Quest medical has reached out to the customer multiple times to request additional information and we have not received any response.A follow-up medwatch will be submitted if additional information becomes available.

Event Description

A report was received regarding an alleged issue encountered with the q2 multiport extension set.The report from the customer states that they are having bubbles created in the device during the infusion.No patient complication was reported.

Manufacturer Narrative

Device evaluation could not be conducted as the complaint sample was not returned.Dhr review could not be conducted because a lot number was not provided by the customer.Samples of the device from another manufcturing lot was tested and no air bubbles were seen.The root cause of the complaint condition is unknown.Quest will continue to monitor complaint trends for the reported complaint condition.

• Brand Name: Q2 MULTIPORT EXTENSION SET - 10 INCH
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen, tx
• MDR Report Key: 9826437
• MDR Text Key: 190526627
• Report Number: 1649914-2020-00016
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K162304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

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
• Device Operator: No Information
• Device Model Number: 9520
• Device Catalogue Number: 9520
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/17/2020
• Initial Date FDA Received: 03/12/2020
• Supplement Dates Manufacturer Received: 02/17/2020
• Supplement Dates FDA Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1