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	Product Quality Problem (1506)
Health Effect - Clinical Codes	Hematoma (1884); Perforation of Vessels (2135)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2026, at 11:00 a.M., a picc catheter was inserted into the patient in accordance with standard operating procedures.After the introducer needle was inserted, good backflow was observed.A guidewire was then advanced; however, resistance was felt at the needle tip, confirming that the needle tip was within the blood vessel and preventing further advancement of the guidewire.The introducer needle was withdrawn, and upon inspection of the guidewire and introducer needle, resistance was noted when the guidewire was advanced to the needle tip, and a barbed tip was discovered on the guidewire.After replacing the catheter with a new one, a new vascular site was selected for puncture.This resulted in the following actual harm and adverse effects to the patient: 1.Secondary mechanical injury to blood vessels and soft tissues: the first puncture had already caused damage to the blood vessels and subcutaneous tissue; due to the catheter placement failure caused by the device malfunction, a site change and repeat puncture were required, leading to secondary injury to the vascular endothelium and subcutaneous tissue, localized puncture pain, and bleeding at the puncture site, as well as subcutaneous bruising and a hematoma.2.Failed catheterization and delayed establishment of access: the failure of this catheterization attempt delayed the establishment of the central venous access required for chemotherapy, causing delays in preparations for subsequent drug infusions.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 device has not been received by the manufacturer for evaluation.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.

• 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: becky sparks ; 605 north 5600 west; salt lake city 84116 ; +1(801)595-0700
• MDR Report Key: 50776468
• Report Number: 3006260740-2026-06717
• Device Sequence Number: 21498850
• 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
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/15/2026
• 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