MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG NXT CLEARVUE 4F CATHETER FULL TRAY (SINGLE-LUMEN) (60CM) (WITH MICROINT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recn0592 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via ms&s patient has a 4fr groshong nxt picc that blew where it meets the connector (portion with writing on it).The nurse stated that when administering contrast for a ct angiogram the catheter blew.Catheter was clamped, but need to know if it is repairable.Ms&s explained that the 4fr groshong nxt can be repaired with a repair kit.Ms&s emailed groshong nxt connector ifu.

• Brand Name: GROSHONG NXT CLEARVUE 4F CATHETER FULL TRAY (SINGLE-LUMEN) (60CM) (WITH MICROINT
• 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: 8295269
• Report Number: 3006260740-2019-00146
• Device Sequence Number: 16779321
• Product Code: LJS
• UDI-Device Identifier: 00801741035258
• UDI-Public: (01)00801741035258
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K034020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/31/2019

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: N/A
• Device Catalogue Number: 7617408
• Device Lot Number: RECN0592
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1