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

Model Number 95906

Device Problems Leak/Splash (1354); Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has been returned for investigation which is in progress.A follow 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 device leaked after it was used with a luer lock access device to draw blood in the er.The nurse replaced the device with a new one and the leakage stopped.There were no patient complications resulting from the alleged issue.

Manufacturer Narrative

A dhr review for the complaint sample could not be completed as the lot number was not provided by the customer.The customer provided a lot number for the devices they have in stock but it is unknown if the complaint sample is from the same lot.As a proactive measure, a review of the dhr for that lot was conducted and no anomalies were identified.A 24 month complaint history review was also conducted and no similar complaint was identified.The complaint sample was received and tearing at the slit of the stem as well as a collapsed stem was observed.A leak test was carried out and the device functioned within specification.A llad device was reportedly used with the complaint sample.A sharp edge on the male luer of the llad may have caused the stem collapse or tear of the slit.Since the llad was not received for evaluation it is unknown if this is the root cause of the alleged issue.The root cause is not manufacturing related.

• 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: 7064298
• MDR Text Key: 93688868
• Report Number: 1649914-2017-00095
• 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: 02/16/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention