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

Catalog Number	NNU6LPT
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a patient underwent an ultrasound guided percutaneous transhepatic cholangiography drainage (ptcd) catheter placement procedure using a navarre universal drainage catheter.During the procedure, it was reported that leakage was observed from a small hole in the sure-lok component during drainage.The procedure was successfully completed using a replacement device.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2026, a patient underwent an ultrasound guided percutaneous transhepatic cholangiography drainage (ptcd) catheter placement procedure using a navarre universal drainage catheter.During the procedure, it was reported that leakage was observed from a small hole in the sure-lok component during drainage.The procedure was successfully completed using a replacement 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 was 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 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.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: although the physical device was not returned for evaluation, two electronic photos were provided for review.The first and second photos show complete views of individual loaded drainage catheters.The third photo shows a complete view of two loaded drainage catheters.The distal end of both catheters noted to be in pigtail condition.The reported fluid leak cannot be verified from the provided photos.The investigation is inconclusive for reported fluid leak issue for both the devices as the provided photo was not sufficient to confirm the 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.G3, h6 (method, result, conclusion).E1: (b)(6).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 Universal 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: 50730781
• Report Number: 3006260740-2026-06632
• Device Sequence Number: 10575167
• Product Code: GBX
• UDI-Device Identifier: 00801741000348
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K951475
• 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: NNU6LPT
• Device Lot Number: GFKN0713
• 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: 08/21/2026
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/11/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2025
• 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