Hickman 0606564Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741052026), received between Aug 11, 2017 and Feb 17, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 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.

• MalfunctionFeb 17, 2021Obstruction of Flow

  IT WAS REPORTED SOMETIME POST CATHETER PLACEMENT, THE DEVICE ALLEGEDLY OCCLUDED. IT WAS FURTHER REPORTED THAT, TPA HAD TO BE USED FREQUENTLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11336748 ↗
• MalfunctionAug 11, 2017Detachment Of Device Component

  IT WAS REPORTED BY THE SALES REP THAT THE FACILITY HAD A DEVICE THAT DURING THE FLUSHING PROTOCOL, AFTER RECEIVING CRYOTHERAPY , THE CATHETER WAS FLUSHED WITH A 10 ML SYRINGE AND THE WHITE PORT POPPED ON THE NURSE. THE CATHETER WAS THEN EXCHANGED WITH A DIFFERENT LOT # AND THE PROCEDURE WAS COMPLETED WITHOUT A PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6788658 ↗
• MalfunctionAug 11, 2017Flushing Problem; Split

  IT WAS REPORTED BY THE SALES REP THAT THE FACILITY HAD A DEVICE THAT DURING THE FLUSHING PROTOCOL, AFTER RECEIVING CRYOTHERAPY, THE CATHETER WAS FLUSHED WITH A 10 ML SYRINGE AND THE TUBING SPLIT NEAR THE HUB. THE CATHETER WAS REMOVED AND REPLACED. 07/25/2017 ADDITIONAL INFORMATION RECEIVED FROM FACILITY: IT WAS REPORTED THAT THEY DIDN¿T USE THE BLUE LUMEN AS THEY COULDN¿T FLUSH IT IN THE ICU BECAUSE IT WAS BALLOONED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6788657 ↗