MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD NEXIVA, BD Q-SYTE; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 383536

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/05/2018

Event Type  malfunction  

Event Description

Was asked to start iv for preop nurse.The patient had excellent veins.#20 gauge iv attempted x2 in right hand.There was no flash into the iv indicating i had hit the vein, however when removing the iv i pulled back the safety mechanism to retract the needle just to see.At that point a gush of blood came back into the iv, though before there was still no flash.The iv was removed.A third stick to the left hand was successful without any malfunction of the iv catheter.I mentioned this to the preop nurses that it just seemed strange what had happened, because the patient had great veins.At that point, i was told that there had been trouble previously with no flash of blood into the ivs.I said, that this was exactly what it felt like had happened.At this point, two pacu nurse managers were informed, and i asked that an email be sent out to staff to let them know if the trouble as i had not head of any issues with the ivs previously.

• Brand Name: BD NEXIVA, BD Q-SYTE
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 7221085
• MDR Text Key: 98313045
• Report Number: 7221085
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835362
• UDI-Public: (01)00382903835362
• 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: 01/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 383536
• Device Catalogue Number: 383536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/13/2018
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 01/13/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 31 YR