MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 8 FRENCH NAVARRE OPTI-DRAIN MULTI-USE DRAINAGE CATHETERS; CHRONIC CATHETER

Catalog Number	NOD8PT
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review was not performed.The sample was returned to bd for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This report summarizes one (1) malfunction.A review of the reported malfunction indicated that model nod8pt chronic catheter allegedly had a fluid leak.This report was received from one source.This malfunction involved a patient with no patient consequences.Age, weight, and gender was not provided for the patient.
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a manufacturing review was not performed.The sample was returned for evaluation.The investigation confirmed for fluid leak and fracture.The definitive root cause could not be determined.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 (1) malfunction.A review of the reported malfunction indicated that model nod8pt chronic catheter allegedly had a fluid leak.This report was received from one source.This malfunction involved a patient with no patient consequences.Age, weight, and gender was not provided for the patient.

• Brand Name: 8 FRENCH NAVARRE OPTI-DRAIN MULTI-USE DRAINAGE CATHETERS
• Common Device Name: CHRONIC CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9593275
• Report Number: 3006260740-2020-00109
• Device Sequence Number: 328038
• Product Code: GBX
• UDI-Device Identifier: 00801741037108
• UDI-Public: (01)00801741037108
• 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): 06/29/2020

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: NOD8PT
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 06/29/2020
• Patient Sequence Number: 1