MAUDE Adverse Event Report: BARD ACCESS SYSTEMS LIFTLOC SAFETY INFUSION SET 19G X 1 IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/01/2019

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of ascqs0076 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported (b)(4) needle safety closure device failed to close, leading to a needle stick on an employee.Facility followed the blood borne pathogen exposure procedure per facility policy and also initiated treatment for the employee and sent the employee to outside facility for prophylactic treatment.Employee will continue to follow up with lab work and prophylactic treatment.No other information was provided.

• Brand Name: LIFTLOC SAFETY INFUSION SET 19G X 1 IN WITH Y-SITE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer Contact: kayla olsen ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225010
• MDR Report Key: 8371567
• MDR Text Key: 137242678
• Report Number: 3006260740-2019-00379
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741047800
• UDI-Public: (01)00801741047800
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013394
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0661910
• Device Lot Number: ASCQS0076
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Manufacturer Received: 02/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention