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

Catalog Number 95906

Device Problems Detachment Of Device Component (1104); Physical Resistance (2578)

Patient Problem Exposure to Body Fluids (1745)

Event Date 05/30/2018

Event Type  malfunction  

Event Description

Nurse was flushing the line and there was a "sudden resistance" at which time the cap came off and fluid sprayed out of the pivo connection port into her eye, face and arm.

• Brand Name: Q2
• Type of Device: IV EXTENSION SET
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 7605349
• MDR Text Key: 111213790
• Report Number: 7605349
• Device Sequence Number: 1
• Product Code: FPK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 11/28/2020
• Device Catalogue Number: 95906
• Device Lot Number: 054872
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/04/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: YES, A PIVO DEVICE
• Patient Age: 66 YR