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

Catalog Number	NNU6LPT
Medical Device Problem Codes	Break (1069); Material Separation (1562); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: although the sample was not returned for evaluation, three electronic photos were provided and reviewed.The first photo shows the product package label in which product details was mentioned and verified with tw details.The second photo show's partial view of a clinician holding the sure loktm thread which was protruding from proximal end of the catheter hub and the thread was not protruding the thread hole on the hub and the catheter appeared pigtailed at the distal end of the catheter.However, the thread was not visible at the distal end of the catheter in the photo due to poor quality image.It was unclear if any thread breaks and separation occurred.The third photo show partial view of a clinician holding the drainage catheter in which thread was protruding from proximal end of the catheter hub and the thread was not protruding the thread hole on the hub.However, the distal end of the catheter was not visible.It was unclear if any thread breaks and separation occurred.Therefore, the investigation is confirmed for the identified device dislodged or dislocated issues.However, the investigation is inconclusive for the reported sure loktm thread break and material separation issues as the provided photo was not sufficient to confirm the reported issues.The definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.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 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) 2026, a patient underwent an ultrasound guided hydrothorax drainage catheter placement procedure using navarre drainage catheter.During the procedure, the sure loktm thread was allegedly digressioned.The procedure was completed using another device.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: 25197326
• Report Number: 3006260740-2026-03429
• Device Sequence Number: 15671845
• Product Code: GBX
• UDI-Device Identifier: 00801741000348
• UDI-Public: (01)00801741000348(11)250822(17)280728(10)GFKT0469
• 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): 04/27/2026

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: NNU6LPT
• Device Lot Number: GFKT0469
• 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: 04/23/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2025
• 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