Navarre Opti Drain
Received Jul 31, 2026 · Event occurred Jul 10, 2026
Report 3006260740-2026-05391 · MDR key 50096457
Device
Generic name
Chronic Catheters
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Catalog number
NOD10LPT
Lot number
GFKP1474
Product problems
- Break
- Material Separation
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
On (b)(6) 2026, a patient underwent an ultrasound guided cyst percutaneous drainage procedure using a Navarre Opti Drain Catheter. During the procedure, the thread became disengaged from the small hole of the Sure-Lok component. The procedure was subsequently completed using an alternative device. 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 is currently being performed. The device has been returned to the manufacturer for evaluation. However, a video and 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.