MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 Navarre Universal Drain; Chronic Catheters

Catalog Number	NNU8PT
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On j(b)(6) 2026, the patient underwent a percutaneous drainage catheter placement procedure using a navarre universal drainage catheter.Post procedure, it was observed that the drainage was significantly slower than expected, with the device used in the peritoneum and gravity flow utilized for drainage.There was no reported patient injury.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records was performed.The return of the sample is pending.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 patient underwent a percutaneous drainage catheter placement procedure using a navarre universal drainage catheter.Post the procedure on (b)(6) 2026, it was observed that drainage through the catheter was significantly slower than expected.The catheter was positioned within the peritoneal cavity, and drainage was being performed by gravity flow.The patient was stable and 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 8fr navarre drainage catheter was returned for evaluation.Visual and functional evaluations were performed on the returned device.The complaint sample was noted to have residue throughout.The catheter appeared to be pigtailed at the distal end.An in-house syringe with dye water was attached to the catheter hub.No defects were noted on the catheter hub with attached syringe.Upon an infusion test, no leaks were observed on the catheter hub; water was observed exiting the distal end of the catheter.The flow of the infusion test appeared to be normal as no resistance was felt.Therefore, the investigation is inconclusive for the restricted flow rate as the sample evaluation results indicating normal flow under laboratory conditions may not be representative of the condition of the device during use.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.B5, e1, 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.

• 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 25618614
• Report Number: 3006260740-2026-04458
• Device Sequence Number: 21365989
• Product Code: GBX
• UDI-Device Identifier: 00801741037016
• UDI-Public: (01)00801741037016(11)260202(17)290128(10)GFKZ0582
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K951475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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: NNU8PT
• Device Lot Number: GFKZ0582
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/25/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 06/25/2026
• Supplement Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2026
• 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