MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 6F NAVARRE UNIVERSAL DRAINAGE CATHETERS WITH NITINOL

Catalog Number	NNU6LP15
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned, however a photo was provided for review.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model nnu6lp15 drainage catheter allegedly experienced a crack.This information was received from a single source.This malfunction involved a patient with no patient injury.The patient's age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation, however, a photo was provided for review.The investigation of the reported event is inconclusive as no sample was returned and the photo did not provided an observable deficiency.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model nnu6lp15 drainage catheter allegedly experienced a crack.This information was received from a single source.This malfunction involved a patient with no patient injury.The patient's age, weight, and gender were not provided.

• Brand Name: 6F NAVARRE UNIVERSAL DRAINAGE CATHETERS WITH NITINOL
• Common Device Name: DRAINAGE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9596041
• Report Number: 3006260740-2020-00122
• Device Sequence Number: 17009582
• Product Code: GBX
• UDI-Device Identifier: 00801741036965
• UDI-Public: (01)00801741036965
• 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,Followup
• Report Date (Section B): 06/25/2020

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 Catalogue Number: NNU6LP15
• Device Lot Number: GFDV1155
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 06/25/2020
• Patient Sequence Number: 1