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

Catalog Number	NNU10LPT
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
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 been returned to the manufacturer for evaluation.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.
Event or Problem Description
A defective navarre 10fr catheter was used during a nephrostomy procedure.The catheter exhibited a crack at the white junction before the drainage connection, resulting in a failure to transcatherize using both amplatz and hydrophilic guides.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: ten (10) 10f navarre drainage catheter sealed lot samples in its original packaging were returned for evaluation.Visual evaluation was performed on the returned device.Sample 1-10: the complaint samples were sealed and all appeared clean.No anomalies were noted throughout all components within the sealed samples.Therefore, the investigation is unconfirmed for the reported hub fracture issues as no anomalies were noted from the returned samples.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) 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
A defective navarre 10fr catheter was used during a nephrostomy procedure.The catheter exhibited a crack at the white junction before the drainage connection, resulting in a failure to transcatherize using both amplatz and hydrophilic guides.There was no reported patient injury.

• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 23400191
• Report Number: 3006260740-2025-08044
• Device Sequence Number: 10034615
• Product Code: GBX
• UDI-Device Identifier: 00801741036903
• UDI-Public: (01)00801741036903(11)250131(17)271228(10)GFJY1748
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 12/25/2025

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: GFJY1748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 12/25/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2025
• 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