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

Catalog Number	NNU8LPT
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A patient underwent an ultrasound guided ascites percutaneous drainage procedure using a navarre universal drainage catheter.On (b)(6) 2026, the drainage catheter connector was found to be fractured.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 physical device was not returned for evaluation, three photos were provided for review.The first photo show's partial view of a clinician holding the drainage catheter implanted into patient body and having residue on the hub.A complete break was noted on the catheter hub, and broken piece was missing in the provided photo.The second photo show's partial view of a clinician holding the drainage catheter and external connector.A longitudinal crack was noted on the catheter hub.The third photo show's partial view of a clinician holding the drainage catheter in which residue was noted on the hub.A longitudinal crack was noted on the catheter hub.Therefore, the investigation is confirmed for the reported drainage catheter connector fracture issues for all the three devices, and the investigation is confirmed for the identified material separation issue for the 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).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: 50649815
• Report Number: 3006260740-2026-06492
• Device Sequence Number: 10485945
• Product Code: GBX
• UDI-Device Identifier: 00801741037009
• UDI-Public: (01)00801741037009(11)251204(17)281128(10)GFKV0345
• 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): 09/19/2026

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: NNU8LPT
• Device Lot Number: GFKV0345
• 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: 08/13/2026
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/07/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2025
• 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