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
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	02/01/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8371567
• Report Number: 3006260740-2019-00379
• Device Sequence Number: 1098828
• Product Code: FPA
• UDI-Device Identifier: 00801741047800
• UDI-Public: (01)00801741047800
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K013394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0661910
• Device Lot Number: ASCQS0076
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention