VISTA BRITE TIP 4038953SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032001004), received between Oct 2, 2019 and Oct 2, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Stretched” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2019Stretched; Unraveled Material; Stretched; Unraveled Material

  AS REPORTED, THERE WAS LEAKAGE FROM THE VISTA BRITE TIP INTRO G 8F STR 95CM .035" SIDE PORT. ADDITIONAL INFORMATION OBTAINED FROM THE PRODUCT ANALYSIS STATES THAT ELONGATION WAS OBSERVED FROM 80.5 CM TO 83.5 CM FROM THE HUB. ADDITIONALLY A LEAK WAS FOUND DUE TO THE CRACK PRESENT IN THE KINK FOUND AT THE JUNCTURE OF THE CATHETER BODY TO THE HUB. THERE WERE NO REPORTED PATIENT INJURIES. THE PRODUCT WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS DIFFICULTY PREPPING THE DEVICE BECAUSE THERE WAS LEAKAGE FROM THE SIDE PORT. THERE WAS NO DAMAGE NOTICED TO THE DEVICE PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE LEAKAGE WAS OBSERVED DURING PREP. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS FINISHED ANOTHER DEVICE. THE DEVICE WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9145259 ↗