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

Model Number 95906

Device Problems Break (1069); 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 follow medwatch will be submitted if additional information becomes available.

Event Description

A customer report received states that the clamps on the extension set side tubing is falling off and at least 2 sets have lost their side clamp.They have had to open a new set to retrieve a clamp for replacement of the defective clamp.

Manufacturer Narrative

The complaint sample was not returned for investigation and no lot number was provided, a dhr review could not be conducted without the lot number.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: 7064304
• MDR Text Key: 93688998
• Report Number: 1649914-2017-00096
• 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: Other
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2017
• 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