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

Model Number	9655405
Health Effect - Clinical Codes	Abdominal Pain (1685); Skin Discoloration (2074); Reaction (2414)
Date of Event	07/19/2017
Type of Reportable Event	Serious Injury
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 rebn1426 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the patient allegedly had a possible reaction to the picc post flush.The patient allegedly started experiencing a increased level of anxiety, upset, crying complaint of mid abdominal pain radiating to the right side of the body and chest.The patient also complained of shortness and difficulty breathing, the patients face was flushed and red.This allegedly occurred when the picc was flushed post trimming and extension leg placed and with the placement of the securacath.The picc was then flushed with 20 ml sterile normal saline.The sherlock navigation system was unable to pick up the tip of the picc during insertion.Picc inserted according to the lums measurement.

• Brand Name: GROSHONG NXT CLEARVUE 4 FR SINGLE LUMEN, BASIC 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: 6803550
• Report Number: 3006260740-2017-01353
• Device Sequence Number: 16433525
• Product Code: LJS
• UDI-Device Identifier: 00801741036026
• UDI-Public: (01)00801741036026
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K063240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: 9655405
• Device Catalogue Number: 9655405
• Device Lot Number: REBN1426
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1