Hickman 0601700Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741036439), received between Feb 6, 2018 and Jul 10, 2023 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jan 4, 2023Open, Classified

   Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable).

   Z-1051-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2023Loss of or Failure to Bond; Material Separation; Device Dislodged or Dislocated; Material Protrusion/Extrusion; Loss of or Failure to Bond; Material Separation; Device Dislodged or Dislocated; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THREE YEARS, ONE MONTH, AND TWENTY-ONE DAYS POST CHRONIC CATHETER PLACEMENT, UPON PERFORMING THE CATHETER REPAIR, A METAL STENT SEGMENT WAS ALLEGEDLY FOUND TO BE PROTRUDING OUT OF THE CATHETER AT AN ANGLE. REPORTEDLY, THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17285042 ↗
• InjurySep 29, 2022Migration; Migration

  IT WAS REPORTED THAT DURING CATHETER PLACEMENT PROCEDURE, THE METAL SEGMENT OF THE REPAIR KIT ALLEGEDLY MIGRATED. CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15501671 ↗
• InjuryAug 8, 2022Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  IT WAS REPORTED THAT POST CATHETER PLACEMENT PROCEDURE, THE METAL SEGMENT OF THE REPAIR KIT ALLEGEDLY DETACHED AND FLOATING IN PATIENT'S LINE. IT WAS FURTHER REPORTED THAT THE METAL SEGMENT ALLEGEDLY MIGRATED. REPORTEDLY DETACHED PART WAS REMOVED AND REPAIRED THE LINE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15181685 ↗
• MalfunctionMay 7, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SOMETIME POST CHRONIC CATHETER PLACEMENT, WHEN REPAIR KIT WAS USED THE CATHETER ALLEGEDLY HAD A LEAK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11788572 ↗
• MalfunctionApr 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT, THE CATHETER ALLEGEDLY HAD LEAKAGE BETWEEN THE TWO CATHETER LINES AT POINT OF BLUNT NEEDLE INSERTION. IT WAS REPORTED THAT PHYSICIAN DID THE REPAIR USING REPAIR KIT AFTER 10 DAYS THE CATHETER ALLEGEDLY LEAKED AGAIN SAME LOCATION OF SEALED JOINT WHILE FLUSHING ON 0.7 MM LINE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11714162 ↗
• MalfunctionMar 25, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A CATHETER PLACEMENT, THE DEVICE ALLEGEDLY HAD LEAKAGE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11566867 ↗
• MalfunctionMar 25, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A CATHETER PLACEMENT, THE DEVICE ALLEGEDLY HAD LEAKAGE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11566866 ↗
• MalfunctionFeb 6, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE NURSE FOUND THE METAL STENT PART TO BE MOVABLE AFTER PRIMING THE PRODUCT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7246315 ↗