MAUDE Adverse Event Report: C.R. Bard, Inc. (BASD) -3006260740 Groshong CLEARVUE; Peripherally Inserted Central Catheter (PICC)

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Pain (1994); Skin Tears (2516)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, at 3:40 p.M., the procedure was performed in accordance with standard operating procedures.During catheter placement, the catheter sheath was inserted approximately 1 centimeter into the skin (1 centimeter of the brown section of the catheter sheath) when difficulty in advancing the catheter was encountered.Upon withdrawing the catheter sheath, it was discovered that the tip of the brown section was fractured and slightly curled.The product was immediately replaced, and a second catheterization was performed on the patient.The ruptured and curled section of the catheter sheath penetrated approximately 1 cm into the subcutaneous tissue, causing mechanical damage to the patient¿s subcutaneous tissue and vascular endothelium, resulting in localized pain.The entire picc kit becomes unusable.No additional information 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.

• Brand Name: Groshong 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: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; +1(801)595-0700
• MDR Report Key: 50757470
• Report Number: 3006260740-2026-06668
• Device Sequence Number: 9241165
• Product Code: LJS
• UDI-Device Identifier: 00801741035272
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K034020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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 Model Number: N/A
• Device Catalogue Number: 7655405
• Device Lot Number: REKU3108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2025
• 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