MAUDE Adverse Event Report: C.R. BARD INC. (BASD) 4 FR SL GROSHONG NXT CLEAR VUE BASIC KIT; LJS

Catalog Number 7617405

Device Problems Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)

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

Event Date 02/26/2014

Event Type  malfunction  

Event Description

The picc was inserted in patient in picc department of this cancer hospital and outflow was found a month later during ward care and outflow was found at 37cm while pulling out.Considering the dependence of the patient on the catheter, cut it to continue to use.The sample cannot be returned.

Manufacturer Narrative

A lot history review (lhr) of rexe1589 showed no other similar product complaint(s) from this lot number.The device has not been returned to the manufacturer at this time for evaluation.

• Brand Name: 4 FR SL GROSHONG NXT CLEAR VUE BASIC KIT
• Type of Device: LJS
• Manufacturer (Section D): C.R. BARD INC. (BASD); salt lake city UT
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas
• Manufacturer Contact: shelly gilbert ; 605 north 5600 west; salt lake city, UT 84116-0000 ; 8015950700
• MDR Report Key: 3874653
• MDR Text Key: 4588798
• Report Number: 3006260740-2014-00201
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K034020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7617405
• Device Lot Number: REXE1589
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2013
• 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