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

Catalog Number	NNU8PT
Medical Device Problem Codes	Collapse (1099); Restricted Flow rate (1248); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow up report will be submitted as applicable.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.
Event or Problem Description
On (b)(6) 2026, the patient underwent a placement procedure during use of a navarre drainage device.During the procedure, occlusions were encountered.The procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2026, the patient underwent a placement procedure during use of a navarre drainage device.During use of the procedure, it was reported that the device was used for large volume paracentesis, with the drain placed in a large pocket of simple fluid.During use, the drain twice stopped functioning despite the tip remaining appropriately positioned within the fluid collection, and no cause for the interruption could be identified.Had drained 1l, stopped spontaneously.Required manipulation/ flushing to restart but occluded multiple times.Drainage resumed only after forceful flushing with saline however, no blood, pus, or visible occlusion was noted within the catheter, suggested a potential concern of catheter wall weakness leading to possible collapse under external pressure.There was no reported patient injury.
Additional Manufacturer Narrative
H11: this supplemental report is submitted to correct an error in the previously submitted reports.The initial mdr and supplemental report 2 listed an incorrect manufacturing location (g1).The correct manufacturing location for this device is c.R.Bard, inc.(gfo).No new event information is being reported in this supplement.Manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.The investigation is inconclusive for the reported obstruction of flow, collapse and restricted flow rate issues as no objective evidence was provided for review.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.G1, g3.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; parque industrial colonial; queensbury 12804
• Manufacturer Contact: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 25172001
• Report Number: 3006260740-2026-03409
• Device Sequence Number: 21382384
• Product Code: GBX
• UDI-Device Identifier: 00801741037016
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup,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: NNU8PT
• Device Lot Number: GFKZ0582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Supplement Date Received by Manufacturer: 05/27/2026; 06/19/2026; 09/21/2026
• Initial Report FDA Received Date: 05/14/2026
• Supplement Report FDA Received Date: 06/15/2026; 06/22/2026; 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2026
• 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