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

Catalog Number	NNU12LPT
Medical Device Problem Codes	Nonstandard Device (1420); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent an ultrasound guided hydrothorax percutaneous drainage catheter placement procedure using navarre universal drainage catheter.During the preparation procedure, the length of the trocar needle was allegedly shorter than the catheter.The procedure was completed using another device.There was no patient contact.
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 return of the sample is pending.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 prepped for an ultrasound guided hydrothorax percutaneous drainage catheter placement procedure using navarre universal drainage catheter.Prior to the procedure, the length of the trocar needle was allegedly shorter than the 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: one 12fr navarre drainage catheter was returned for evaluation.Visual and functional evaluations were performed on the returned device.The inner stylet was returned within the cannula and catheter.The inner stylet and cannula were not locked into place at the catheter hub.The distal tip of the stylet was not noted at the distal end of the catheter.An attempt to load the inner stylet into the cannula was performed and was successful with slight resistance.The stylet and cannula locked into place without issue.An attempt to load the inner stylet and the cannula into the catheter was performed and was successful with slight resistance.The stylet and cannula locked into place without issue.The distal tip of the stylet was slightly noted at the distal end of the catheter.Based on measurements, the measured length of the catheter and the length of the stylet needle the protruding portion of the stylet is within specifications.Therefore, the investigation is unconfirmed for the reported length of trocar shorter than the catheter issue.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.D4 (unique identifier (udi) #), g3, h6 (device, 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 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: 22466855
• Report Number: 3006260740-2025-04649
• Device Sequence Number: 12726011
• Product Code: GBX
• UDI-Device Identifier: 00801741036934
• UDI-Public: (01)00801741036934(11)240228(17)270128(10)GFHZ0723
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2025

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: NNU12LPT
• Device Lot Number: GFHZ0723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2024
• 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