MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PowerPort ClearVUE Slim Implantable Port, ChronoFlex Single-Lumen, Kit, 6F; Port & Catheter, Implanted, Subcutaneous, Intravascular

Catalog Number	1616070
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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.
Event or Problem Description
On (b)(6) 2025, a patient underwent a port placement procedure using the powerport clearvue slim.During the procedure, the valve equipped sheath failed to tear properly at the straight cut where the airguard was engaged.The remainder of the sheath was peeled away, and the procedure was completed.There was no reported patient injury.

• Brand Name: PowerPort ClearVUE Slim Implantable Port, ChronoFlex Single-Lumen, Kit, 6F
• Common Device Name: Port & Catheter, Implanted, Subcutaneous, Intravascular
• 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 24968222
• Report Number: 3006260740-2026-02775
• Device Sequence Number: 17388209
• Product Code: LJT
• UDI-Device Identifier: 00801741026461
• UDI-Public: (01)00801741026461(11)250506(17)270131(10)REKQ1811
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2026

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: 1616070
• Device Lot Number: REKQ1811
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/20/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Supplement Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2025
• 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
• Patient Sex: Unknown