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

Catalog Number	NOD8J
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 devices were provided, a lot history review could be performed.The samples were not returned to the manufacturer for inspection/evaluation, however, a photo was provided for one malfunction for review.The investigation of the reported event is currently underway.The device was labeled for single use.
Event or Problem Description
This report summarizes two malfunction.A review of the reported information indicated that model nod8j chronic catheter allegedly experienced crack on the hub of the catheter and leakage.This information was received from multiple source.The two reported malfunction involved two patient with no consequences.The two male patients were reported to be between (b)(6) years old, and weighed between (b)(6) kgs.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model nod8j chronic catheter allegedly experienced crack on the hub of the catheter and leakage.This information was received from multiple source.The two reported malfunction involved two patient with no consequences.The two male patients were reported to be between 50 to 62 years old and weighed between 57 to 60 kgs.
Additional Manufacturer Narrative
H10: the lot number for the devices were provided, therefore, a lot history reviews were performed.The samples were not returned to the manufacturer for inspection/evaluation; however, a photo was provided and reviewed for one malfunction.For 1 of 2 malfunctions, the investigation is confirmed for the reported fracture and leakage issues.The remaining malfunction is inconclusive for the reported catheter hub crack and leak issue.A definitive root cause could not be determined based upon available information.The devices are labeled for single use.

• Brand Name: 8 FRENCH NAVARRE OPTI-DRAIN MULTI-USE DRAINAGE CATHETERS
• Common Device Name: CHRONIC CATHETERS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10759299
• Report Number: 3006260740-2020-03572
• Device Sequence Number: 11705490
• Product Code: GBX
• UDI-Device Identifier: 00801741037085
• UDI-Public: (01)00801741037085
• 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): 01/12/2021

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: NOD8J
• Device Lot Number: GFDY3016
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 01/13/2021
• Patient Sequence Number: 1