Hickman 0600600Recalls & reported problems
Bard Access Systems, Inc. · Hickman 9 Fr Dual-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Bard Hickman dual-lumen catheter, a long-term central line placed in a large vein, has 116 adverse event reports on file. Many describe fluid or blood leaking, and others describe cracks, fractures or the line bursting during placement or use. The reports include no deaths and 10 injuries, and a few describe medication leaking outside the vein. 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
- 116
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 116 adverse event reports that list this exact device (DI 00801741051890), received between Feb 27, 2016 and Jan 17, 2025 — classified as 10 injuries, 106 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (57 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
- Fluid/Blood Leak57
- Fracture39
- Burst Container or Vessel20
- Break8
- Material Puncture/Hole6
- Obstruction of Flow6
- Difficult to Flush5
- Hole In Material5
Patient problems
- No Clinical Signs, Symptoms or Conditions47
- No Consequences Or Impact To Patient35
- No Known Impact Or Consequence To Patient24
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available7
- Extravasation3
- Hematoma2
- Injury2
- Pain2
Recent adverse event reports
The 25 most recent of 116 reports, in the reporter's own words as published by the FDA.
InjuryJan 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, THERE WAS ALLEGEDLY AN EXTRAVASATION OF MEDICATION THROUGH A POINT/FISSURE. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Extravasation
MAUDE report 21177587 ↗MalfunctionMar 22, 2024Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY FOUND TO BE OCCLUDED RIGHT AFTER INSERTION. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18957874 ↗MalfunctionFeb 14, 2024Fracture; Fracture
IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, A CRACK WAS ALLEGEDLY NOTICED IN THE DISTAL PART OF THE CATHETER'S WHITE LINE WHEN DISINFECTING AND CHANGING THE GAUZE AROUND THE CATHETER. REPORTEDLY, THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18701192 ↗MalfunctionJan 8, 2024Burst Container or Vessel; Fluid/Blood Leak; Burst Container or Vessel; Fluid/Blood Leak
IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, THE PATIENT ALLEGEDLY HEARD A POP WHILE FLUSHING. IT WAS FURTHER REPORTED THAT THE WHITE LUMEN HAD A LEAK AND THERE WAS BLOOD PRESENT. REPORTEDLY, THE LINE WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18462187 ↗MalfunctionSep 18, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE IN RIGHT EXTERNAL JUGULAR VEIN, THE GUIDEWIRE WAS ALLEGEDLY WRAPPED WITH THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17763660 ↗MalfunctionAug 9, 2023Burst Container or Vessel; Fluid/Blood Leak; Difficult to Flush; Fracture; Burst Container or Vessel; Fluid/Blood Leak; Difficult to Flush; Fracture
IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS POST CHRONIC CATHETER PLACEMENT, A CUT WAS ALLEGEDLY FOUND AT THE LUMEN OF THE CATHETER. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY NOT ABLE TO BE FLUSHED, AND BLOOD ALLEGEDLY LEAKED FROM THE CATHETER. REPORTEDLY, THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17486998 ↗MalfunctionJul 14, 2023Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, A FISSURE WAS ALLEGEDLY NOTICED IN THE DISTAL PART OF THE WHITE PATHWAY, WHICH REQUIRED AN INTERRUPTION OF SERUM THERAPY AND THE PASSAGE OF A NEW CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17324511 ↗MalfunctionMay 18, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY FRACTURED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16955019 ↗MalfunctionMay 17, 2023Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT SOMETIME POST CHRONIC CATHETER PLACEMENT, THE PATIENT EXPERIENCED SWELLING AND DEVICE ALLEGEDLY TEND TO OCCLUDE. IT WAS FURTHER REPORTED THAT, THE CATHETER WAS USED USING SOLUBILIZER. REPORTEDLY, THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16944083 ↗MalfunctionMay 9, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
IT WAS REPORTED THAT ONE YEAR AND EIGHT DAYS POST CHRONIC CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY TORN OFF DURING FLUSHING. IT WAS FURTHER REPORTED THAT BLOOD WAS ALLEGEDLY LEAKING FROM THE INSERTION SITE. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16893862 ↗MalfunctionApr 18, 2023Difficult to Flush; Suction Problem; Difficult to Flush; Suction Problem
IT WAS REPORTED THAT POST PORT PLACEMENT, ONE CHANNEL WAS SLUGGISH AND THAT WAS NOTICED AFTER FIRST USE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16760314 ↗MalfunctionApr 13, 2023Stretched; Material Protrusion/Extrusion; Stretched; Material Protrusion/Extrusion
IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS PLACED IN PATIENT BUT WHEN ONE LUMEN WAS INJECTED THE CATHETER ALLEGEDLY BALLOONED UP IN FRONT OF THE CATHETER CLAMP. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16740437 ↗MalfunctionApr 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT POST A CHRONIC CATHETER PLACEMENT, THE PATIENT EXPERIENCED PAIN UPON BUILDUP OF ADHESIVE ON THE OUTSIDE OF THE CATHETER CLOSE TO THE INSERTION SITE MAKING IT DIFFICULT TO CLEAN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16662513 ↗InjuryFeb 9, 2023Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT TWENTY FOUR DAYS POST CHRONIC CATHETER PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED PAIN OVER CATHETER INSERTION SITE AND MILD SWELLING WAS NOTED UNDER RIGHT CLAVICLE AREA. IT WAS FURTHER REPORTED THAT THE PATIENT WAS TREATED WITH BASIC PAIN MANAGEMENT AND ANTI-INFLAMMATORY DRUGS TO TREAT PAIN. REPORTEDLY THAT CATHETER WAS REMOVED AND EXCHANGED TO TREAT PAIN AND SWELLING. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Pain; Swelling/ Edema
MAUDE report 16331504 ↗MalfunctionDec 15, 2022Burst Container or Vessel; Material Puncture/Hole; Burst Container or Vessel; Material Puncture/Hole
IT WAS REPORTED THAT ONE MONTH POST CATHETER PLACEMENT PROCEDURE, THE LINE ALLEGEDLY HAD HOLE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15984423 ↗MalfunctionOct 11, 2022Fracture; Fracture
IT WAS REPORTED THAT SOMETIMES POST CATHETER PLACEMENT PROCEDURE, THE WHITE ROUTE OF THE CATHETER ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15575971 ↗MalfunctionAug 26, 2022Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
IT WAS REPORTED THAT SOME TIME POST CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY LEAKED FROM THE BIFURCATION SITE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15299867 ↗MalfunctionJul 21, 2022Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
IT WAS REPORTED THAT FOUR DAYS POST CATHETER PLACEMENT PROCEDURE, THE LEAKAGE WAS ALLEGEDLY NOTED. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY FOUND TO BE BROKEN. THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15073296 ↗MalfunctionJul 19, 2022Fracture; Fracture
IT WAS REPORTED THAT TWO DAYS POST CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY FRACTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15050906 ↗MalfunctionMay 23, 2022Fracture; Improper or Incorrect Procedure or Method; Fracture; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT SOMETIME POST CHRONIC CATHETER PLACEMENT, THE PHYSICIAN FORGOT TO UNCLAMP THE PORT. IT WAS FURTHER REPORTED THAT THE LUMEN ALLEGEDLY CRACKED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14469822 ↗MalfunctionMay 4, 2022Difficult to Flush; Difficult to Flush
IT WAS REPORTED THAT TWO DAYS POST CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY HAD A DIFFICULTY IN FLUSHING. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14284248 ↗MalfunctionMay 4, 2022Fracture; Fracture
IT WAS REPORTED THAT PRIOR TO A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY DAMAGED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14274968 ↗MalfunctionMar 17, 2022Delivered as Unsterile Product; Peeled/Delaminated; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Peeled/Delaminated; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT UPON RECEIVING THE PACKAGE OF THE DEVICE, THE BOX AND THE PRODUCT ALLEGEDLY FOUND TO BE DAMAGED AND COMPONENT LOST STERILITY. IT WAS FURTHER REPORTED THAT THE BOX AND THE PRODUCT INSIDE ARE DAMAGED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13791904 ↗MalfunctionMar 16, 2022Fracture; Fracture
IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS POST CATHETER PLACEMENT, THE CATHETER ALLEGEDLY RUPTURED AT THE TIME OF FLUSHING WITH SALINE. IT WAS FURTHER REPORTED THAT CATHETER WAS REMOVED FROM PATIENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13786525 ↗MalfunctionFeb 1, 2022Burst Container or Vessel; Fracture; Burst Container or Vessel; Fracture
IT WAS REPORTED THAT TWO MONTHS AND TWENTY ONE DAYS POST CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT CATHETER NEEDS TO BE REMOVED DUE TO FRACTURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13412235 ↗
Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices
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- PowerPICC SOLO2 Catheter 1194108DBard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 recalls216 reports
- Broviac 0600520Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall265 reports
- Groshong® Catheter 7717405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days279 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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