MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG NXT PICC WITH SHERLOCK TIP LOCATION SYSTEM 4F BASIC TRAY (SINGLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	9655405
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2018
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, as the device is being retained by the patient.A lot history review (lhr) of rebp1118 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that during inspection of the catheter while flushing on (b)(6) 2018, "there was bulging noted at the clear part of the line." the picc was repaired rather than removed, and is still in the patient.No patient injury reported.

• Brand Name: GROSHONG NXT PICC WITH SHERLOCK TIP LOCATION SYSTEM 4F BASIC TRAY (SINGLE-LUMEN)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7664737
• Report Number: 3006260740-2018-01644
• Device Sequence Number: 1384077
• 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): 07/05/2018

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 Model Number: 9655405
• Device Catalogue Number: 9655405
• Device Lot Number: REBP1118
• 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: 07/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1