MAUDE Adverse Event Report: C.R. Bard, Inc. (BASD) -3006260740 Navarre Opti Drain; Chronic Catheters

Catalog Number	NOD8LPT
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A patient underwent an ultrasound guided ascites percutaneous drainage catheter placement procedure using a navarre opti drain catheter.Following the procedure on (b)(6) 2026, fluid leakage was observed from the small hole of the sure-lok component.The procedure was subsequently completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: although the sample was not returned for evaluation, one electronic photo and two videos were provided for review.The first video shows partial view of a clinician holding the drainage catheter.Fluid leak was noted connection between hub and catheter.The second video shows partial view of a clinician holding two implanted drainage catheters.Fluid leakage was observed at the junction between the catheter hub and the catheter in both drainage catheters.The photo shows the partial view of clinician holding three drainage catheter packaging.The product label along with a catheter was partially visible for one packaging.Therefore, the investigation is confirmed for the reported fluid leak issue for this first device.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.E1: (b)(6).G3, h6 (component, method, result, conclusion).Section a through f: the information provide by bd represents all 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.

• Brand Name: Navarre Opti Drain
• Common Device Name: Chronic Catheters
• Manufacturer (Section D): C.R. Bard, Inc. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): C.R. Bard, Inc. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50565717
• Report Number: 3006260740-2026-06379
• Device Sequence Number: 15941542
• Product Code: GBX
• UDI-Device Identifier: 00801741037092
• UDI-Public: (01)00801741037092(11)250515(17)280428(10)GFKR0815
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: Unknown
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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 Catalogue Number: NOD8LPT
• Device Lot Number: GFKR0815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown