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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
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 not been returned to the manufacturer for evaluation.However, a photo was 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 underwent an ultrasound-guided percutaneous drainage catheter placement procedure using navarre opti drain.Post the procedure, after returning to the ward postoperatively, leakage occurred at the connection point of the catheter tip.The leaking at the connector was caused by a cracked drain tubing.The connecting tube was immediately removed, and a rubber connector was reapplied to seal the tear at the catheter tip.The issue was resolved by replacing the leaking rubber connector.There were no reported patient injuries.
Event or Problem Description
On (b)(6) 2025, a patient underwent an ultrasound guided percutaneous drainage catheter placement procedure using navarre opti drain.Post the procedure, after returning to the ward postoperatively, leakage occurred at the connection point of the catheter tip.The leaking at the connector was caused by a cracked drain tubing.The connecting tube was immediately removed, and a rubber connector was reapplied to seal the tear at the catheter tip.The issue was resolved by replacing the leaking rubber connector.There were no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the sample was not returned for evaluation.One electronic photo was provided for review.The photo shows partial view of drainage catheter implanted in patient body.The catheter hub was connected with drainage bag connector, and no visual anomalies were noted in the provided photo.Therefore, the investigation is inconclusive for the reported fracture and fluid leak issues as there was no objective evidence obtained from the provided photo.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G3, h6 (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.

• 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: 24018820
• Report Number: 3006260740-2025-10348
• Device Sequence Number: 16090765
• Product Code: GBX
• UDI-Device Identifier: 00801741037061
• UDI-Public: (01)00801741037061(17)280228(10)GFKN1768
• 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): 02/23/2026

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: NOD12LPT
• Device Lot Number: GFKN1768
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 03/02/2026
• 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