MAUDE Adverse Event Report: QUEST MEDICAL, INC Q2 IV EXTENSION SET; IV EXTENSION SETS

Model Number 95906

Device Problems Component Falling (1105); Loose or Intermittent Connection (1371); No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

At the time of this report, the device has not been returned for investigation.A dhr/process review will be conducted and a follow medwatch will be submitted if additional information becomes available.

Event Description

A customer report received states that the white clamps on the extension sets have been very loose and have been falling off.The report also states that the staff have had to clamp the tubing so there is no chance for communication from any saline or solution left in the tubing being drawn back and in cases with iv fluid running the staff have had to disconnect the fluids.There were no reported patient complications resulting from the alleged issue.

Manufacturer Narrative

The complaint sample was not returned for investigation.A dhr review was conducted and no anomalies were found.A sample of the device from existing inventory at quest was evaluated and the slide clamp was inspected and was found to be within specifications.The root cause of the issue complained about is unknown.As a proactive measure, a capa has been initiated to evaluate the effect of possible alternate clamp styles that may be used on the device.

• Brand Name: Q2 IV EXTENSION SET
• Type of Device: IV EXTENSION SETS
• 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: 7064316
• MDR Text Key: 93689035
• Report Number: 1649914-2017-00098
• Device Sequence Number: 1
• Product Code: FPK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162804
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 95906
• Device Lot Number: 054629
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention