MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG NXT CLEARVUE 4 FR SINGLE LUMEN, FULL TRAY WITH MI; PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER

Catalog Number	9617408
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/23/2013
Type of Reportable Event	Malfunction
Additional 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.A lot history review (lhr) of rexj0803 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Patient reported that she had a picc line placed in (b)(6) 2013.A home health nurse placed a bio-patch at the picc site.The patient stated that when the nurse was changing the dressing, they cracked the picc.Patient reported that they had an x-ray done that showed that the picc was kinked and coiled inside the body.The picc was removed (b)(6) 2014, and a new picc was placed.On 12/05/2016 - per patient's email, she stated that the saline would not flow, and when she looked at the dressing closely through the clear tegaderm, she could see that the line was folded onto itself (similar to completely bending a plastic straw in half).The patient then called the after-hours service and told the nurse that the picc looked kinked and folded over.The nurse went to the patient¿s house, removed the dressing and both nurse and patient could see that the line was folded over.The patient stated that they saw what looked like a hairline crack on the side at the fold.The patient reported that the nurse pushed the line into the patient¿s arm which was painful for the patient.The nurse then applied a new dressing.The patient tried to start the doxycycline infusion and about 10 ml went in but it stung badly under the skin.On (b)(6), an x-ray showed that the line was coiled and bent under the skin.The picc was removed and a new picc was inserted the same day.

• Brand Name: GROSHONG NXT CLEARVUE 4 FR SINGLE LUMEN, FULL TRAY WITH MI
• Common Device Name: PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6157937
• Report Number: 3006260740-2016-00663
• Device Sequence Number: 10958442
• Product Code: LJS
• UDI-Device Identifier: 00801741036002
• UDI-Public: (01)00801741036002(17)150430(10)REXJ0803
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 11/18/2016

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: 04/30/2015
• Device Catalogue Number: 9617408
• Device Lot Number: REXJ0803
• Was Device Available for Evaluation?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1