MAUDE Adverse Event Report: QUEST MEDICAL, INC. Q2 EXTENSION SET, 17 INCH; INTRAVASCULAR ADMINISTRATION SET

Model Number 95902

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device was discarded by the customer and the lot number was not provided.A follow up medwatch will be submitted if additional information becomes available.

Event Description

A customer reported an issue encountered with the q2 extension set.The report states that the patient notified the registered nurse that the bite infusion tubing filter was leaking.About 1 sheet size of paper spill on bed soaked into sheets - patient was not sitting in it.One drop of bite was found on the patient's arm.Infusion was immediately stopped and the pharmacy and attending were notified there were no reported patient complications resulting from the alleged issue.

Manufacturer Narrative

A dhr review could not be completed because the device was discarded by the end user and no lot number was provided.A review of complaints in the last 24 months identified one similar complaint which could not be confirmed because the device was also discarded.A process review was conducted and no anomalies were identified.A quality alert has been issued to manufacturing personnel to raise awareness about the alleged issue as a precautionary measure.Quest medical will continue to monitor complaint trends.

• Brand Name: Q2 EXTENSION SET, 17 INCH
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer Contact: tosan onosode ; one allentown parkway; allen, TX 75002 ; 9723326338
• MDR Report Key: 7064301
• MDR Text Key: 93601619
• Report Number: 1649914-2017-00097
• Device Sequence Number: 1
• Product Code: FPK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2018

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: Nurse
• Device Model Number: 95902
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/07/2017
• Initial Date FDA Received: 11/28/2017
• Supplement Dates Manufacturer Received: 11/07/2017
• Supplement Dates FDA Received: 01/09/2018
• 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): Required Intervention