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

Catalog Number	NNU8LPT
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a patient underwent a computed tomography guided percutaneous transhepatic cholangiography drainage (ptcd) catheter placement procedure using a navarre universal drainage catheter.During the procedure, it was reported that the sure-lok thread completely disengaged from the catheter.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H11: e1 - (b)(6).H.4.Device manufacture date: unknown.Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this lot.Investigation summary: although the physical device was not returned for evaluation, two photos were provided for review.The first photo shows the physician holding an implanted drainage catheter in one hand, and on the other hand, physician holding thread which was completely separated from hub.The second photo shows a clinician holding a drainage catheter in one hand and the detached thread in the other hand, with glue visible at the end of the separated thread.Therefore, the investigation is confirmed for the reported thread break and material separation issues.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.Section a through f: the information provided by bd represents all of 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: 50837140
• Report Number: 3006260740-2026-06833
• Device Sequence Number: 18657044
• Product Code: GBX
• UDI-Device Identifier: 00801741037009
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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: NNU8LPT
• Device Lot Number: GFKU0587
• 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: 08/30/2026
• Initial Report FDA Received Date: 09/21/2026
• 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
• Patient Sex: Unknown