MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NAVARRE BILIARY DRAINAGE CATHETER 10FR

Model Number	NBD10
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not be performed.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 instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Event or Problem Description
It was reported that post drainage tube exchange, the patient's caregiver found that the hub of the tube had allegedly cracked which had caused leaking.It was further reported that the drainage tube was exchanged again.There was no reported patient injury.

• Brand Name: NAVARRE BILIARY DRAINAGE CATHETER 10FR
• Common Device Name: NAVARRE BILIARY DRAINAGE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8356554
• Report Number: 3006260740-2019-00326
• Device Sequence Number: 2198556
• Product Code: FGE
• UDI-Device Identifier: 00801741036842
• UDI-Public: (01)00801741036842
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K955110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/20/2019

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: NBD10
• Device Catalogue Number: NBD10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 02/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1