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

Catalog Number	NOD8LPT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a patient underwent an ultrasound guided percutaneous transhepatic cholangial drainage procedure using the navarre opti drain drainage catheter.After the procedure, the drainage catheter connector fractured.The procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
A patient underwent an ultrasound guided percutaneous transhepatic cholangiography drainage (ptcd) catheter placement procedure using a navarre opti drain catheter.Following the procedure, on (b)(6)2026, it was reported that the drainage catheter connector was fractured.The procedure was completed using another device.There was no reported patient injury.
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 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.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this lot.Investigation summary: although the physical device was not returned for evaluation, one photo was provided and reviewed.The photo shows a partial view of a clinician holding a drainage catheter connected to an external connector.A longitudinal crack was noted on the catheter hub.The investigation is confirmed for the reported drainage catheter connector fracture issue.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 (guangzhou first people's hospital, guangzhou first people's hospital affiliated to guangzhou medical college) h.4.Device manufacture date: unknown.B5, g3, h6 (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: 50665183
• Report Number: 3006260740-2026-06499
• Device Sequence Number: 10174964
• Product Code: GBX
• UDI-Device Identifier: 00801741037092
• 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): 09/17/2026

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: GFKW0887
• 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: 08/17/2026
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/08/2026
• Supplement Report FDA Received Date: 09/23/2026
• 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