BRITE TIP 401823MRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705032000383), received between Jul 22, 2021 and Apr 29, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, AN 8F 23 CM BRITE TIP CATHETER SHEATH INTRODUCER (CSI) BROKE OFF INSIDE THE PATIENT. THE PHYSICIAN WAS FIGURE 8 SUTURING THE ACCESS SITE TO REMOVE THE SHEATH WHEN THIS OCCURRED. MANUAL REMOVAL WAS ATTEMPTED WITH NO SUCCESS. THE PATIENT WAS THE CONVERTED FROM MONITORED ANESTHESIA CARE TO GENERAL ANESTHESIA FOR VASCULAR SURGERY TO MAKE AN INCISION AND EXTRACT THE SHEATH. THE SHEATH TIP WAS REMOVED SUCCESSFULLY FROM THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION AS PREVIOUSLY EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19201521 ↗
• InjurySep 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A PIECE OF AN 8F BRITE TIP 23CM STR SHEATH BROKE OFF DURING REMOVAL AND REMAINED IN THE PATIENT. THE DEVICE WAS FLUSHED PRIOR TO USE. THE VESSEL DILATOR WAS SNAPPED INTO PLACE AT THE HUB. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING THE INSERTION PROCESS. THERE WERE NO DAMAGES NOTED TO THE DEVICE PRIOR TO USING IT. THE PATIENT WAS STABLE AND DISCHARGED. THE VESSEL AT THE INSERTION SITE WAS NOT NOTED AS A DIFFICULT SITE ACCORDING TO THE PHYSICIAN OPERATION (OP) NOTE. THE DISTAL PORTION, BLACK END THAT IS RADIOPAQUE BROKE OFF INTO THE PATIENT. THERE WAS NO ATTEMPT TO REMOVE THE PIECE THAT BROKE OFF. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 17844087 ↗
• MalfunctionJul 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  WHEN THE CUSTOMER OPENED THE 8F 23CM STRAIGHT (STR) BRITE TIP CATHETER SHEATH INTRODUCER (CSI), IT WAS NOTED THAT THE BRITE TIP/DISTAL TIP WAS FRACTURED-SEPARATED. THE DEVICE WAS NEVER USED IN THE PATIENT. THE DEVICE WAS STORED PER LABELLING. THE PROCEDURE WAS COMPLETED WITH ANOTHER 8X23 SHEATH. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12208713 ↗