TruGuide
Received Jul 28, 2026 · Event occurred Jul 3, 2026
Report 2020394-2026-01930 · MDR key 50049421
Device
Generic name
Biopsy Instrument
Manufacturer
Bard Peripheral Vascular, Inc.Catalog number
C1416A
Lot number
REKZ1787
Product problems
- Illegible Information
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
On (b)(6)2026, a patient underwent a biopsy procedure using the TruGuide. Prior to the procedure, it was observed that the batch number and expiry date on the labeling were printed in very small text and was difficult to read. There was no patient contact.This is report 3 of 15.
Additional Manufacturer Narrative
H11: This report was impacted by eMDR scheduled maintenance occurring July 22-27, 2026.As the lot number for the device was provided, a review of the Device History Records is currently being performed. The device has not been returned to the manufacturer for evaluation. However, Photo was provided for review. The investigation of the reported event is currently underway.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.