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

Catalog Number	NNU10LPT
Medical Device Problem Codes	Nonstandard Device (1420); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent an endoscopic guided ascites drainage catheter placement procedure using navarre drainage catheter.Prior to the procedure, the length of trocar needle was allegedly longer than catheter.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records was 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.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one 10f navarre drainage catheter locking pigtail segment with a flexible cannula was received for evaluation.Visual, functional and dimensional evaluation were performed.An attempt to load the inner stylet into the cannula and catheter was performed and was successful after small pressure was applied.The stylet and cannula locked into place without issue.The distal tip of the stylet was noted to protrude at the distal end of the catheter.Based on the measurements recorded for length of stylet including hub and protruding portion of stylet at distal end of catheter, during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.Therefore, the investigation is unconfirmed for the reported trocar needle being longer than the catheter 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.D1, g3, h6 (device, 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.
Event or Problem Description
On (b)(6) 2025, a patient underwent an endoscopic guided ascites drainage catheter placement procedure using navarre drainage catheter.Prior to the procedure, the length of trocar needle was allegedly longer than catheter.The procedure was completed using another device.There was no patient contact.

• Brand Name: NAVARRE UNIVERSAL DRAINAGE CATHETER
• 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: 22892294
• Report Number: 3006260740-2025-06228
• Device Sequence Number: 8896562
• Product Code: GBX
• UDI-Device Identifier: 00801741036903
• UDI-Public: (01)00801741036903(11)240919(17)270828(10)GFJU2489
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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: NNU10LPT
• Device Lot Number: GFJU2489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2024
• 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