MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG NXT 5F DUAL-LUMEN REVERSE TAPER PICC BASIC TRAY WITH SAFETY INTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the picc line inserted by consultant anaesthetist on subsequent investigation for ct -radiologist noticed that all thorax vessels were not as enhanced as expected and there was suspicion that picc was not functioning properly so it was removed.On close examination of picc was found to have a hole in the midline.No harm to patient or healthcare professional.

• Brand Name: GROSHONG NXT 5F DUAL-LUMEN REVERSE TAPER PICC BASIC TRAY WITH SAFETY INTRODUCER
• 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: 10049783
• Report Number: 3006260740-2020-01717
• Device Sequence Number: 3292767
• Product Code: LJS
• UDI-Device Identifier: 00801741035340
• UDI-Public: (01)00801741035340
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K023374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2020

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: 11/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 7827505
• Device Lot Number: RECZ0232
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 05/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1