MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NAVARRE OPTI DRAIN; CHRONIC CATHETERS

Catalog Number	NOD12LPT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.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
A patient underwent an ultrasound guided percutaneous transhepatic biliary drainage catheter placement procedure using navarre opti-drain drainage catheter.On (b)(6) 2025, after the procedure, a break occurred in the body of the drainage catheter.The catheter was replaced with a new drainage catheter.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2025, a patient underwent an ultrasound-guided hydrothorax percutaneous drainage catheter placement procedure using navarre opti drain catheter.Post the procedure, a break occurred in the body of the drainage catheter.The catheter was replaced with a new drainage catheter.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: although the sample was not returned for evaluation, two electronic photos were provided and reviewed.The photo the shows the partial view of catheter and hub.Device appeared to be clean; water droplets were noted on the device.Partial break was noted on the tip of the catheter.Therefore, the investigation is confirmed for the reported catheter fracture.The definitive root cause could not be determined based upon available information.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 23704150
• Report Number: 3006260740-2025-09199
• Device Sequence Number: 18802003
• Product Code: GBX
• UDI-Device Identifier: 00801741037061
• UDI-Public: (01)00801741037061(17)271128(10)GFJX0707
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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: NOD12LPT
• Device Lot Number: GFJX0707
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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