Hickman TriFusion 0609190Recalls & reported problems
Bard Access Systems, Inc. · Hickman TriFusion Triple Lumen Long Term Central Venous Catheter 12F with Intermediate Tray · Class 2 · Implant
Quick summary
This Bard Hickman TriFusion catheter is a long-term triple-lumen central venous catheter. Reports mostly describe parts breaking or separating and devices arriving without labels, including air found in tubing during placement. There are 33 reports naming its identifier, with no deaths and 5 injuries mentioned, with 1 report in the last 12 months compared with 7 in the prior 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00801741036521), received between Jul 12, 2018 and Jun 19, 2026 — classified as 6 injuries, 28 malfunctions.
The most frequently reported specific device problem is “Fracture” (9 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture9
- Component Missing8
- Missing Information7
- Defective Component5
- Break4
- Material Separation4
- Fluid/Blood Leak3
- Air/Gas in Device2
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- No Consequences Or Impact To Patient5
- Pain4
- No Patient Involvement2
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
- Pulmonary Embolism1
- Thrombosis/Thrombus1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
InjuryJun 19, 2026Device Appears to Trigger Rejection; Obstruction of Flow
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, ON (B)(6) 2017, A PATIENT UNDERWENT PORT PLACEMENT FOR CHEMOTHERAPY. APPROXIMATELY ONE YEAR, THREE MONTHS AND ELEVEN DAYS LATER, ON (B)(6) 2018, THE PATIENT WAS DIAGNOSED WITH THROMBOSIS AND PULMONARY EMBOLISM. SUBSEQUENTLY, THE PORT WAS REMOVED ON (B)(6) 2018. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.
Patient problems: Pulmonary Embolism; Thrombosis/Thrombus
MAUDE report 25560804 ↗MalfunctionJan 13, 2026Decrease in Suction; Restricted Flow rate; Suction Problem; Air/Gas in Device
ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN TRIFUSION CENTRAL VENOUS CATHETER. ON (B)(6) 2025, DURING THE PROCEDURE INLET TUBING NOTED TO HAVE AIR MIXED IN WITH BLOOD DURING ASPIRATION. ON (B)(6) 2025, CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24050369 ↗MalfunctionDec 24, 2024Component Missing; Missing Information; Component Missing; Missing Information
IT WAS REPORTED THAT DURING PREPARATION FOR A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY RECEIVED WITHOUT LABEL. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21013117 ↗MalfunctionDec 24, 2024Component Missing; Missing Information; Component Missing; Missing Information
IT WAS REPORTED THAT DURING PREPARATION FOR A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY RECEIVED WITHOUT LABEL. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21013102 ↗MalfunctionDec 24, 2024Component Missing; Missing Information; Component Missing; Missing Information
IT WAS REPORTED THAT PRIOR TO A CHRONIC CATHETER PLACEMENT PROCEDURE, THE LABELS WERE ALLEGEDLY MISSING IN THE RECEIVED CATHETER. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21010771 ↗MalfunctionDec 23, 2024Component Missing; Missing Information; Component Missing; Missing Information
IT WAS REPORTED THAT DURING THE PREPARATION OF CHRONIC CATHETER PLACEMENT PROCEDURE, THE DEVICE WAS ALLEGEDLY RECEIVED WITHOUT LABELS. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21009462 ↗MalfunctionDec 23, 2024Component Missing; Missing Information; Component Missing; Missing Information
IT WAS REPORTED THAT DURING PREPARATION FOR A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY RECEIVED WITHOUT LABEL. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21000857 ↗MalfunctionDec 23, 2024Component Missing; Missing Information; Component Missing; Missing Information
IT WAS REPORTED THAT DURING PREPARATION FOR A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY RECEIVED WITHOUT LABEL. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21000606 ↗MalfunctionDec 23, 2024Component Missing; Missing Information; Component Missing; Missing Information
IT WAS REPORTED THAT PRIOR TO A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY RECEIVED WITHOUT LABEL. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21000489 ↗MalfunctionAug 7, 2024Unsealed Device Packaging; Component Missing; Packaging Problem; Unsealed Device Packaging; Component Missing; Packaging Problem
IT WAS REPORTED THAT PRIOR TO A CHRONIC CATHETER PLACEMENT PROCEDURE, THE PACKAGE RECEIVED WAS ALLEGEDLY DAMAGED AND EMPTY. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19935327 ↗MalfunctionJun 29, 2024Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE AIR WAS ALLEGEDLY ENTERED IN THE LINE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19640388 ↗MalfunctionApr 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE PLASTIC PIECE OF TUNNELLER ALLEGEDLY SLIPPED OFF AT THE END OF TUNNELER AND HAD TO BE REMOVED FROM PATIENT'S SKIN WITH A HEMOSTAT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19048972 ↗MalfunctionMar 4, 2024Fluid/Blood Leak; Fracture; Material Separation; Fluid/Blood Leak; Fracture; Material Separation
IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY GOT SNAPPED INTO TWO PIECES. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD A LEAK. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18824353 ↗InjuryFeb 23, 2024
PLASTIC PIECE OF TUNNELER SLIPPED OFF END OF TUNNELER AND HAD TO BE REMOVED FROM UNDER PATIENTS' SKIN WITH A HEMOSTAT. THIS IS THE SECOND CATHETER THAT THIS HAS OCCURRED. REFERENCE REPORT: MW5151886.
Patient problems: Insufficient Information
MAUDE report 18776824 ↗MalfunctionNov 1, 2023Loss of or Failure to Bond; Material Separation; Loss of or Failure to Bond; Material Separation
IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, DURING REMOVAL OF THE CATHETER, THE CUFF WAS ALLEGEDLY NOT PRESENT ON THE CATHETER AND WAS FOUND TO BE DETACHED FROM THE CATHETER. REPORTEDLY, PATIENT WAS ELECTED TO HAVE A SECONDARY PROCEDURE TO REMOVE THE CUFF, WHICH DID NOT REQUIRE GENERAL ANESTHESIA. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18049880 ↗MalfunctionOct 16, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT SOMETIME POST CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY LEAKED UPON INFUSION. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17937390 ↗MalfunctionAug 8, 2023Difficult to Remove; Stretched; Deformation Due to Compressive Stress; Difficult to Remove; Stretched; Deformation Due to Compressive Stress
IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE GUIDEWIRE WAS ALLEGEDLY UNRAVELED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17479088 ↗MalfunctionMay 15, 2023Fracture; Fracture
IT WAS REPORTED THAT SOMETIME POST CATHETER PLACEMENT, THE LINE WAS ALLEGEDLY CRACKED AT JUNCTION REINFORCED LINE WITH SLIM LINE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16928971 ↗MalfunctionApr 21, 2023Fracture; Material Separation; Fracture; Material Separation
IT WAS REPORTED THAT SOMETIME POST CHRONIC CATHETER PLACEMENT, THE CLAMP OF THE WHITE LUMEN ALLEGEDLY BROKE WHEN TRIED TO OPEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16789919 ↗MalfunctionNov 23, 2022Fracture; Fracture
IT WAS REPORTED THAT FOUR MONTHS AND TEN DAYS POST CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15850110 ↗MalfunctionJul 21, 2021Fracture; Material Separation; Fracture; Material Separation
IT WAS REPORTED THAT DURING A TUNNELING PROCESS, THE TUNNELER OF THE DEVICE ALLEGEDLY BROKE. THE BROKEN PIECE WAS RETRIEVED FROM UNDER THE SKIN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12201144 ↗MalfunctionJul 9, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT SOMETIME POST CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY LEAKED. THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12141152 ↗InjuryMay 25, 2021Break; Fracture; Break; Fracture
IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT ON RIGHT SIDE UPPER CHEST INTERNAL JUGULAR, THE CATHETER END ALLEGEDLY BROKEN AND PATIENT EXPERIENCING PAIN. IT WAS FURTHER REPORTED THAT CATHETER WAS REPLACED WITH ANOTHER ONE. PATIENT REPORTED STABLE.
Patient problems: Pain
MAUDE report 11874886 ↗InjuryMay 25, 2021Break; Fracture; Break; Fracture
IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT ON RIGHT SIDE UPPER CHEST INTERNAL JUGULAR, THE CATHETER END ALLEGEDLY BROKEN AND PATIENT EXPERIENCING PAIN. IT WAS FURTHER REPORTED THAT CATHETER WAS REPLACED WITH ANOTHER ONE. PATIENT REPORTED STABLE.
Patient problems: Pain
MAUDE report 11874873 ↗InjuryMay 25, 2021Break; Fracture; Break; Fracture
IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT ON RIGHT SIDE UPPER CHEST INTERNAL JUGULAR, THE CATHETER END ALLEGEDLY BROKEN AND PATIENT EXPERIENCING PAIN. IT WAS FURTHER REPORTED THAT CATHETER WAS REPLACED WITH ANOTHER ONE. PATIENT REPORTED STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions; Pain
MAUDE report 11874860 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.