MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT CLEARVUE; PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)

Catalog Number	7812400
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that after picc catheter placement on (b)(6) 2025, at the picc clinic, fluid leakage was observed at the pressure relief sleeve during flushing and sealing after connection of the replacement single-lumen connector.Inspection revealed damage to the pressure relief sleeve.The catheter was cut at the tip of the sleeve, and a new replacement single-lumen connector was opened and connected for continued use.No serious harm was caused to the patient.No further information was provided.
Additional Manufacturer Narrative
H11: section a through f: the information provided by bd represents all of 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.Each event reported to bd is evaluated and investigated in accordance with our complaint investigation procedures.The investigation process includes, but is not limited to, evaluation of the event details provided by the complaint facility, a review of complaint history, manufacturing records and risk document where applicable, and an evaluation of the subject device when available to identify potential contributing factors.The device has not been returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of 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.The complaint of a leaking catheter is confirmed and was determined to be related to use of the product.One assembled 4 fr groshong nxt two-piece connector was returned for evaluation.An initial visual observation of the returned two-piece connector showed blood residues along the device.The two-piece connector was assembled upon return of the device.The clear oversleeve of the distal connector was observed to be removed from the device.A small portion of a groshong catheter was observed inside the distal connector.The distal connector piece was carefully removed to observe the catheter shaft inside the device.A functional test of pressurizing the catheter shaft with water after removal of the distal connector revealed a leak along the catheter shaft.After removing the distal connector piece from the device, the catheter shaft was visible.Microscopic inspection of the catheter shaft showed indentations from where the compression sleeve compressed the catheter shaft.A small circumferential split was observed just distal to the compression section of the catheter shaft.The split was observed to be at the distal end of the metal sleeve of the proximal connector.The split was observed to have rounded, polished fracture edges and a granular fracture surface.The root cause of this failure was determined to be caused by bunching of the catheter during assembly of the device, causing the catheter to rub against the metal cannula and contribute to a split in the catheter.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: GROSHONG NXT CLEARVUE
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: veronica lee ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23729182
• Report Number: 3006260740-2025-09369
• Device Sequence Number: 15869889
• Product Code: LJS
• UDI-Device Identifier: 00801741075261
• UDI-Public: (01)00801741075261(11)240427(17)290228(10)REJQ1275
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K034020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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: 7812400
• Device Lot Number: REJQ1275
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown