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

Catalog Number	NNU12LPT
Medical Device Problem Codes	Nonstandard Device (1420); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent a placement procedure of navarre universal drainage.Prior to the procedure placement procedure, the plastic tip of the drain allegedly extends beyond the metal tip of the mandrel after the drain is assembled.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 is currently being performed.The return of sample is pending.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: two 12f navarre drainage catheters were returned for sample evaluation.Along with return sample five photos were provided for the review.Visual, microscopic visual, functional and dimensional evaluations were performed.The distal tip of the stylet was not noted at the distal end of the catheter for one devices and stylet was not noted to be protrude at the distal end of the catheter for second device.The inner stylet and cannula were locked into place at the catheter hub.No blood residues were noted.Functional testing was performed and successful both the devices.Dimensional evaluation was performed, and stylet were noted to be out of specification for both the devices.Stylets were not protruding from catheter tip for one catheter and slightly protruding from another catheter, stylet length issues were noted for both the device in photo review.Therefore, the investigation is confirmed for the reported short metal trocar stylet length issues for both the device.A definitive root cause could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D4 (unique identifier (udi) #), g3, h6 (device, component, 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 a percutaneous drainage placement procedure using the navarre universal drainage.Prior to the procedure, it was reported that the plastic tip of the drain allegedly extends beyond the metal tip of the mandrel after the drain is assembled.There was no patient contact.

• 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: 23447535
• Report Number: 3006260740-2025-08253
• Device Sequence Number: 9008449
• Product Code: GBX
• UDI-Device Identifier: 00801741036934
• UDI-Public: (01)00801741036934(11)240229(17)270128(10)GFHZ0729
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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): 12/22/2025

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: NNU12LPT
• Device Lot Number: GFHZ0729
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• 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