MAUDE Adverse Event Report: BECTON DICKINSON & COMPANY BD VACUTAINER ULTRATOUCH PUSH BUTTON BLOOD COLLECTION SET; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Lot Number 7334586

Device Problems Retraction Problem (1536); Device Operates Differently Than Expected (2913)

Patient Problems Bruise/Contusion (1754); Hemorrhage/Bleeding (1888); Injury (2348); Needle Stick/Puncture (2462)

Event Date 04/17/2018

Event Type  malfunction  

Event Description

In the past month, we have had the following occurrences regarding this device: while performing venipuncture during the ultratouch push button bd vacutainer blood collection set, the needle retracted while still drawing blood.The tourniquet was still in place therefore the patient was bleeding from the site and started to bruise immediately.(reported as device 1).While performing venipuncture during the ultratouch push button bd vacutainer blood collection set, the needle retracted while still drawing blood.The tourniquet was still in place therefore the patient was bleeding from the site and started to bruise.(reported as device 3).3)employee injury: after obtaining lab work from patient i went to pick up the butterfly needle that was used to put in the sharps container.I am not sure how, but the needle punctured my left middle finger.To note, when i was obtaining patient's labs, the safety feature on the needle went off while the needle was in the patient's vein, even though i had not pushed the button.The labs had not been obtained yet so i had to get another needle to obtain the labs.There were no problems noted with the second attempt.The needle that i stuck myself with was from the first attempt, which the safety feature went off without me touching it.(reported as device 3) unfortunately none of these devices was retained however the lot# was retained on the first two events.I am unsure of the lot# associated with the employee injury.

• Brand Name: BD VACUTAINER ULTRATOUCH PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BECTON DICKINSON & COMPANY; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 7467914
• MDR Text Key: 106718003
• Report Number: 7467914
• Device Sequence Number: 1
• Product Code: JKA
• 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: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 11/30/2019
• Device Lot Number: 7334586
• 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: 04/19/2018
• Date Report to Manufacturer: 04/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.
• Patient Outcome(s): Other