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

Catalog Number	7857505
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
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.The manufacturer has received the sample and it will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported by the customer that the groshong was inserted on (b)(6) 2025 with requested removal from clinician on (b)(6) 2025 due to product fault.It was noticed on pulsatile flushing the clear section between the hub and red lumen "bulges" out.Doctor requested it to be removed.Patient undergoing chemo, groshong was removed and replaced same day.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.The complaint of catheter ¿bulging¿ was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 5fr dual lumen groshong catheter.Usage residues were observed throughout the sample and needleless injection caps were attached to both luer adapters.Attempts to infuse water through the sample using a 12ml syringe revealed both lumens to be patent; however, when flushing the red-luered lumen, ballooning of the extension tubing was observed just distal of the white sleeve.Tactile inspection of the sample revealed tensile weakness, necking and discoloration in the red-luered extension tubing, just distal of the white sleeve.Microscopic inspection of the sample revealed superficial stress cracks within the ballooned region of the extension tubing.The tensile weakness, necking, stress fractures and ballooning were all consistent with tensile damage or over-pressurization of the indwelling catheter.

• Brand Name: GROSHONG NXT
• 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: 21900349
• Report Number: 3006260740-2025-02555
• Device Sequence Number: 8623340
• Product Code: LJS
• UDI-Device Identifier: 00801741035388
• UDI-Public: (01)00801741035388(11)240219(17)260131(10)REJP1356
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K023374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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 Expiration Date: 01/31/2026
• Device Catalogue Number: 7857505
• Device Lot Number: REJP1356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• 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