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

Catalog Number	NNU10LPT
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
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 return of the sample is pending.The investigation of the reported event is currently underway.Section a through f ¿ the information provided 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 navarre universal drainage catheter placement.It was reported that post a catheter placement, the white connecting hub of the drain was allegedly found broken.The drain has been replaced.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: one 10fr navarre drainage catheter was returned for evaluation.Visual and microscopic evaluations were performed on the returned device.A crack was noted on one side of the catheter hub.The edges of the crack on the catheter hub were noted to be jagged.The surface could not be determined.A complete circumferential break was noted on the center portion of the catheter body.What appeared to be a coil, was noted keeping both breaks' sides together.The edges of the complete circumferential break on the center portion of the catheter were noted to be jagged.One break side appeared circular, and the other break side appeared elliptical in shape.The surfaces were noted to be granular throughout both sides.Two splits were noted, one on each side of the catheter body.The edges were noted to be jagged.Therefore, the investigation is confirmed for the reported catheter hub fracture, catheter tube fracture and material separation issues.The definitive root cause could not be determined based upon available information.Labelling 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 (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 navarre universal drainage catheter placement.It was reported that post a catheter placement, the white connecting hub of the drain was allegedly found broken.The drain has been replaced.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: one 10fr navarre drainage catheter was returned for evaluation.Visual and microscopic evaluations were performed on the returned device.A crack was noted on one side of the catheter hub.The edges of the crack on the catheter hub were noted to be jagged.The surface could not be determined.A complete circumferential break was noted on the center portion of the catheter body.What appeared to be a coil, was noted keeping both breaks' sides together.The edges of the complete circumferential break on the center portion of the catheter were noted to be jagged.One break side appeared circular, and the other break side appeared elliptical in shape.The surfaces were noted to be granular throughout both sides.Two splits were noted, one on each side of the catheter body.The edges were noted to be jagged.Therefore, the investigation is confirmed for the reported catheter hub fracture and the identified catheter tube fracture, catheter tube material separation issues.However, the investigation is unconfirmed for the reported catheter hub material separation 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.G3, h6 (component) 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 navarre universal drainage catheter placement.It was reported that post a catheter placement, the white connecting hub of the drain was allegedly found broken.Further, it was reported that the catheter was completely broken.The drain has been replaced.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: 23847251
• Report Number: 3006260740-2025-09845
• Device Sequence Number: 10030378
• Product Code: GBX
• UDI-Device Identifier: 00801741036903
• UDI-Public: (01)00801741036903(11)250630(17)280428(10)GFKP1050
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Followup
• Report Date (Section B): 03/03/2026

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: NNU10LPT
• Device Lot Number: GFKP1050
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 02/11/2026; 03/03/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/18/2026; 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2025
• 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