MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 600 ML NAVARRE® UNIVERSAL GRAVITY DRAINAGE BAG; DRAINAGE CATHETER ACESSORY

Model Number	NDB600
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
For the reported event, lot number was not provided.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device was labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model ndb600 drainage catheter accessory allegedly experienced fluid leak.This report was received from a single source.This event did involve patient with no reported patient injury.Age, weight, and gender were not provided for the patient.

• Brand Name: 600 ML NAVARRE® UNIVERSAL GRAVITY DRAINAGE BAG
• Common Device Name: DRAINAGE CATHETER ACESSORY
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9975064
• Report Number: 3006260740-2020-01430
• Device Sequence Number: 4597826
• Product Code: EXF
• UDI-Device Identifier: 00801741036880
• UDI-Public: (01)00801741036880
• 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): 04/17/2020

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: No Information
• Device Model Number: NDB600
• Device Catalogue Number: NDB600
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/17/2020
• Patient Sequence Number: 1