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

Device Problem Material Integrity Problem (2978)

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

Event Date 05/24/2018

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 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 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)
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• 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: tesha udy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225819
• MDR Report Key: 7664737
• MDR Text Key: 113552552
• Report Number: 3006260740-2018-01644
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741036026
• UDI-Public: (01)00801741036026
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K063240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 9655405
• Device Catalogue Number: 9655405
• Device Lot Number: REBP1118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2017
• 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