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

Catalog Number	NNU10LPT
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a patient underwent percutaneous drainage catheter placement procedure.Post procedure the sure loktm thread allegedly had digression.Furthermore break was also reported.The procedure was completed by using another device.There was no 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.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) 2026, a patient underwent ascites percutaneous drainage catheter placement procedure.Post procedure the sure lok tm thread allegedly had digression.Furthermore, break was also reported.The procedure was completed by using another device.There was no patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one 10f navarre drainage catheter was returned for evaluation, and one electronic photo was provided for the review.The photo shows the packaged drainage catheter along with its product label in which product details was mentioned and verified with tw details.Visual, microscopic and functional evaluations were performed on the returned device.The seal base adapter thread-hole appeared to be opened with no sign of thread inside.The proximal and distal thread holes were inspected, and no sign of thread was found.What appeared to be a thread segment, was observed protruding a center drainage hole.A complete circumferential break was noted on the exposed end of the thread segment.The surface appeared to be granular throughout.The detached pigtail thread was microscopically observed.No knots were noted on both ends of the detached thread; complete circumferential breaks were noted on both ends of the thread.The surfaces of both ends appeared to be granular.The manufacturing review was performed and states that the thread was detached at the pigtail.Therefore, the investigation is confirmed for the reported break and material separation issues.A definitive root cause could not be determined based upon the provided information.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D4(unique identifier), 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 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: 24374671
• Report Number: 3006260740-2026-00911
• Device Sequence Number: 5572141
• Product Code: GBX
• UDI-Device Identifier: 00801741036903
• UDI-Public: (01)00801741036903(11)241127(17)271028(10)GFJX0492
• 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): 03/26/2026

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: NNU10LPT
• Device Lot Number: GFJX0492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• 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