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

Catalog Number	NNU8LP15
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	09/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: although the physical device was not returned for evaluation, two photos were provided for review.The photos show partial view of a clinician holding an implanted drainage catheter attached to an external connector.A crack was noted on the catheter hub.Therefore, the investigation is confirmed for reported catheter connector fracture and fluid leak issues for one device and due to the absence of supporting evidence, the investigation is inconclusive for reported catheter connector fracture and fluid leak issues for another device.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, 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 ultrasound guided ascites drainage catheter placement procedure using navarre drainage catheter.After the procedure, the drainage catheter was allegedly fractured.Additionally, leak was noted at the connector.Reportedly extravasation was identified.The procedure was completed using another device.The current status of the patient was unknown.
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 not been returned to the manufacturer for evaluation.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.
Event or Problem Description
On (b)(6) 2025, a patient underwent an ultrasound guided ascites drainage catheter placement procedure using navarre drainage catheter.After the procedure, the drainage catheter was allegedly fractured.Additionally, leak was noted at the connector.Reportedly extravasation was identified.The procedure was completed using another device.The current status of the patient was unknown.

• 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: 23121067
• Report Number: 3006260740-2025-07123
• Device Sequence Number: 9416897
• Product Code: GBX
• UDI-Device Identifier: 00801741036996
• UDI-Public: (01)00801741036996(17)260828(10)GFHV1033
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2026
• Device Catalogue Number: NNU8LP15
• Device Lot Number: GFHV1033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown