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

Catalog Number	NOD12LPT
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260); Material Separation (1562); Air/Gas in Device (4062)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	09/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records was performed.The device has not been returned to the manufacturer for evaluation.However, 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.
Event or Problem Description
On (b)(6) 2025, a patient diagnosed with thymoma underwent thoracoscopic extended thymectomy with right lower lobe wedge resection using the navarre opti drain.Post procedure, a tube was retained for pleural fluid and air drainage.Later a minor leakage was observed at the chest tube connector, and examination revealed a fracture in the rigid section of the connector.The patient reported mild chest tightness with oxygen saturation at 95%, and auscultation showed slightly diminished breath sounds on the right side.The drainage tube connector was replaced, and a chest x-ray revealed a small pneumothorax.The patient was instructed to cough to expel trapped air, after which chest tightness resolved, oxygen saturation improved to 99%, and breath sounds normalized.The patient remained under observation and was later discharged without further complications.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: the physical device was not returned for evaluation.First photo shows the physician holding the drainage catheter connector hub which was noted to be fractured.The second photo shows the physician holding completely fractured connector hub in which blood stains were noted in one of the fractured segment and material separation is identified.Therefore, the investigation is confirmed for the reported fracture, fluid leak, air/gas in device since it is cascading and identified material separation.The definitive root cause could not be determined based upon available information.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G3, h6 (device, component, 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.
Event or Problem Description
On (b)(6) 2025, a patient diagnosed with thymoma underwent thoracoscopic extended thymectomy with right lower lobe wedge resection using the navarre opti drain.Post procedure, a tube was retained for pleural fluid and air drainage.Later a minor leakage was observed at the chest tube connector, and examination revealed a fracture in the rigid section of the connector.The patient reported mild chest tightness with oxygen saturation at 95%, and auscultation showed slightly diminished breath sounds on the right side.The drainage tube connector was replaced, and a chest x-ray revealed a small pneumothorax.The patient was instructed to cough to expel trapped air, after which chest tightness resolved, oxygen saturation improved to 99%, and breath sounds normalized.The patient remained under observation and was later discharged without further complications.The current status of the patient is unknown.

• 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: 23580834
• Report Number: 3006260740-2025-08738
• Device Sequence Number: 9533114
• Product Code: GBX
• UDI-Device Identifier: 00801741037061
• UDI-Public: (01)00801741037061(11)250227(17)280128(10)GFKN0719
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: NOD12LPT
• Device Lot Number: GFKN0719
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown