Hickman 0601690Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741036422), received between Jan 12, 2017 and Sep 15, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT PROCEDURE, THE RED ADAPTER LEG ALLEGEDLY BROKEN AT THE SAME SPOT. IT WAS FURTHER REPORTED THAT THE LUMEN WAS REPAIRED FOR THE THIRD TIME WITH THE REPAIR KIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15425502 ↗
• MalfunctionSep 15, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT PROCEDURE, THE RED ADAPTER LEG ALLEGEDLY BROKEN AT THE SAME SPOT. IT WAS FURTHER REPORTED THAT THE LUMEN WAS REPAIRED FOR THE THIRD TIME WITH THE REPAIR KIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15425441 ↗
• MalfunctionSep 14, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT PROCEDURE, THE RED ADAPTER LEG ALLEGEDLY BROKEN AT THE SAME SPOT. IT WAS FURTHER REPORTED THAT THE LUMEN WAS REPAIRED FOR THE THIRD TIME WITH THE REPAIR KIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15416327 ↗
• MalfunctionSep 14, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT PROCEDURE, THE RED ADAPTER LEG ALLEGEDLY BROKEN AT THE SAME SPOT. IT WAS FURTHER REPORTED THAT THE LUMEN WAS REPAIRED FOR THE THIRD TIME WITH THE REPAIR KIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15416324 ↗
• MalfunctionAug 17, 2022Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT PROCEDURE, THE RED ADAPTER LEG ALLEGEDLY BROKEN AT THE SAME SPOT. IT WAS FURTHER REPORTED THAT THE LUMEN WAS REPAIRED FOR THE THIRD TIME WITH THE REPAIR KIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15238764 ↗
• MalfunctionMay 31, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FACILITY HAS ALLEGED THE CATHETER HAS HOLES IN THE TUBING, SMALL SPLITS IN THE TUBING AND/OR SEPARATION AT THE REPAIR KIT. THE CATHETER WAS REPAIRED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 7558995 ↗
• MalfunctionJan 12, 2017Hole In Material

  FACILITY CONTACT REPORTED THAT A DLHL 7FR LINE WAS PLACED ON (B)(6) 2016. ON (B)(6) 2016, A PINPOINT HOLE WAS REPORTABLY NOTED AT THE HUB OF THE RED LUMEN. LINE REPAIR REQUIRED. PATIENT WILL BE FOLLOWED ON TO SEE IF LINE INFECTION DETECTED 7 DAYS BEFORE OR AFTER LINE REPAIR OCCURRED. WILL NOTIFY BARD FIELD ASSURANCE IF LINE INFECTION FOUND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6247542 ↗