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

Catalog Number	NOD8LPT
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, the patient underwent a placement procedure in preparation for an ultrasound guided percutaneous drainage procedure for cyst management.Prior to use, it was reported that the trocar needle length was significantly longer than the associated drainage catheter.The procedure was completed using another device.There was no patient contact.
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, one electronic photo was provided and reviewed.The photo shows the partial view of three catheters along with loaded trocar needle.The needle tip was noted to be protruding from the tip and thread was noted in the distal tip of the catheter.However the hub is not visible and it is difficult to analyze without complete view and without physical sample.Therefore, the investigation is inconclusive for the reported trocar needle length longer than the catheter issue for all three devices as it is not sufficient enough to determine whether the product did not meet specifications.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 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 OPTI 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: 25662964
• Report Number: 3006260740-2026-04564
• Device Sequence Number: 10452503
• Product Code: GBX
• UDI-Device Identifier: 00801741037092
• UDI-Public: (01)00801741037092(11)250509(17)280428(10)GFKR0296
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2026

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: NOD8LPT
• Device Lot Number: GFKR0296
• 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: 06/09/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2025
• 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