MAUDE Adverse Event Report: C.R. Bard, Inc. (BASD) -3006260740 PowerPort ClearVUE isp Implantable Port, ChronoFlex Single-Lumen, 8F; Port & Catheter, Implanted, Subcutaneous, Intravascular

Catalog Number	5608062
Medical Device Problem Codes	Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Pain (1994); Skin Discoloration (2074)
Date of Event	07/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately eight years ago, a patient underwent a port placement procedure using a power port clear vue isp.On (b)(6) 2026, following treatment administration through the port, the patient removed the dressing and observed blood on it.It was further reported that there was yellowish green discoloration of the skin, consistent with a healing bruise, along with pain at the site.The current patient condition is unknown.
Event or Problem Description
Approximately eight years ago, a patient underwent port placement procedure using a powerport clearvue isp.On (b)(6) 2026, following treatment administration through the port, the patient removed the dressing and observed blood on it.It was further reported that there was yellowish green discoloration of the skin, consistent with a healing bruise, along with pain at the site.The current patient condition is unknown.
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Section a through f: the information provide by bd represents all 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.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.The investigation is inconclusive for the reported pain, skin discoloration and bruise issues as no objective evidence was provided for review.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G3, h6 (patient, device, component).Section a through f: the information provide by bd represents all 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, 8F
• 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: 50137670
• Report Number: 3006260740-2026-05427
• Device Sequence Number: 18761626
• Product Code: LJT
• UDI-Device Identifier: 00801741027369
• UDI-Public: (01)00801741027369
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K122899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 5608062
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Supplement Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 08/17/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown