MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SECURELOC SAFETY INTRODUCER NEEDLE 21G X 2.75 IN; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reep3239 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported facility had an issue yesterday with the bard securelock safety introducer needle lot # reep3239.After accessing and threading the wire into the vein, the proceduralist removed the needle and pulled the green safety slide down toward the tip of the needle.The green slide actually slide past the needle tip and completely off exposing the tip of the needle that was utilized to access the patient¿s vein.This needle was not in the custom kits but dropped independently onto the sterile field.

• Brand Name: SECURELOC SAFETY INTRODUCER NEEDLE 21G X 2.75 IN
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10258664
• Report Number: 3006260740-2020-02378
• Device Sequence Number: 2912118
• Product Code: DYB
• UDI-Device Identifier: 00801741041716
• UDI-Public: (01)00801741041716
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: S03021-275
• Device Lot Number: REEP3239
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 07/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1