MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY (WITH MICROINTRODUCER) (EX; PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER

Catalog Number 7655405J

Device Problems Fluid/Blood Leak (1250); Kinked (1339); Material Rupture (1546); Device Dislodged or Dislocated (2923)

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

Event Date 12/18/2015

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 was discarded at (b)(4) due to expire of stock period after visual inspection.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Discarded at (b)(4) due to the expire of stock period after visual inspection.

Event Description

It was reported that the catheter rupture and the leakage were found when flushing.Also, the catheter kink was observed.The catheter placed out side of the patient body (from hub to catheter connector) had not been covered by dressing.The catheter had been placed in the right brachium.

• Brand Name: GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY (WITH MICROINTRODUCER) (EX
• Type of Device: PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 6722089
• MDR Text Key: 80464883
• Report Number: 3006260740-2017-01067
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K034020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7655405J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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