MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UDC 8F PIGTAIL; NAVARRE UNIVERSAL DRAINAGE CATHETER

Catalog Number	NNU8PT
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction.A review of the event indicated that model nnu8pt experienced a fluid leak.This report was received from one source.The device was used in the patient.There was no reported patient injury.

• Brand Name: UDC 8F PIGTAIL
• Common Device Name: NAVARRE UNIVERSAL DRAINAGE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8818410
• Report Number: 3006260740-2019-02123
• Device Sequence Number: 19634784
• Product Code: GBX
• UDI-Device Identifier: 00801741037016
• UDI-Public: (01)00801741037016
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2019

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: No Information
• Device Catalogue Number: NNU8PT
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1