MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN 12 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF TI; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 0600620

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer for evaluation, as the device remains in the patient.A lot history review (lhr) of hubq1697 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the patient's mother that her son has a 12f dl hickman cvc.She states she has been locking it with ethanol per the physicians orders.She reported having occasional difficulty getting blood return.She stated that the nurse instilled heparin yesterday and was then able to get blood return.There was no reported patient injury.

• Brand Name: HICKMAN 12 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF TI
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 7441890
• MDR Text Key: 105919707
• Report Number: 3006260740-2018-00745
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741051913
• UDI-Public: (01)00801741051913
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K830233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 0600620
• Device Catalogue Number: 0600620
• Device Lot Number: HUBQ1697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2017
• 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