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

Catalog Number	1606062
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a patient underwent a port placement procedure using the powerport clearvue isp.Post procedure, it was reported that an x ray was performed to assess for complications and confirmed that the ct marker was inverted; however, the cv port itself was not inverted.A review of 50 cases implanted during august identified one additional case with a similarly inverted marker.It was further noted that the issue was initially identified in a batch manufactured on august 27, and a retrospective review revealed the same issue in a batch manufactured on august 14.There was no reported patient injury.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records will be performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.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.

• Brand Name: PowerPort ClearVUE isp Implantable Port, ChronoFlex Single-Lumen, 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: 50865155
• Report Number: 3006260740-2026-06913
• Device Sequence Number: 15808798
• Product Code: LJT
• UDI-Device Identifier: 00801741026416
• UDI-Public: (01)00801741026416(17)271130(10)RELN0704
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063377
• 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
• Report Date (Section B): 09/02/2026

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: 1606062
• Device Lot Number: RELN0704
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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