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

Model Number	N/A
Medical Device Problem Codes	Misassembled (1398); Misconnection (1399)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that on 2/4 picc inserted via right ulnar vein, about 27 cm, 22 mar nurse call from patient at 15:30, found picc detached from fixture.The patient said that it got caught when he tried to lie down.Picc reinsertion.There was no reported patient injury.No other 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.The complaint of a catheter misconnection is confirmed and was determined to be use-related.One 4 fr s/l groshong catheter and its two-piece connector attached to a statlock stabilization device was returned for evaluation.An initial visual observation of the returned devices revealed blood use residues throughout the returned devices.The catheter was detached from the two-piece connector.A tactile evaluation of the returned catheter revealed tensile weakness at the proximal end of the detached catheter.The catheter connector was disassembled, and the distal connector piece was bisected longitudinally to observed what material was left inside the connector.A microscopic observation revealed no catheter remains were observed along the metal cannula of the proximal connector.It was observed that no catheter remains were observed inside the distal connector after the device was bisected longitudinally.The investigation findings are consistent advancement of the compression sleeve prior to insertion of the catheter.Insertion of flushing adaptors, or other devices, into the distal connector piece will change the position of the inner catheter compression sleeve and render the connector unusable for later assembly.Additionally, the connector assembly should not be preassembled or pre-fit prior to the final assembly step as this will also advance the inner catheter compression sleeve.The product ifu contains instructions for proper product assembly and adherence to the instruction steps will avoid this type of event.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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21941874
• Report Number: 3006260740-2025-02744
• Device Sequence Number: 8836523
• Product Code: LJS
• UDI-Device Identifier: 00801741035449
• UDI-Public: (01)00801741035449
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K034020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2025

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 Model Number: N/A
• Device Catalogue Number: 7655405
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 07/12/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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