PowerPort ClearVUE Slim Implantable Port, ChronoFlex Single-Lumen, Kit, 6F
Received Jul 31, 2026 · Event occurred Jul 20, 2026
Report 3006260740-2026-05389 · MDR key 50096237
Device
Generic name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Catalog number
1616000
Lot number
Unknown
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Unspecified Infection
Narrative
Description of Event or Problem
It was reported through the litigation process that, sometime after the port placement, the patient was diagnosed with an unspecified infection. However, the current status of the patient was unknown.
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 medical records were provided for review. The investigation is inconclusive for the reported infection as no objective evidence was provided for review. Based upon the available information, the definitive root cause is unknown. Labeling Review: As the reported event did not allege a labeling or use related issue, a Labeling Review is not required. 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.