Port Access Needle SHG19-75Recalls & reported problems
Bard Access Systems, Inc. · EZ Huber 19ga x 3/4in · Class 2
All models of Port Access Needle (122)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bard EZ Huber needle is used to access implanted venous ports for infusions. The 58 reports mostly describe packaging and component problems — sealed packaging that wasn't sealed, broken parts, and needles without needle guards — along with blood leaking from the tubing or a clamp that wouldn't close, and ports that could no longer be flushed. No deaths or injuries are reported. 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
- 58
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00801741089138), received between Jun 16, 2017 and May 23, 2024 — classified as 58 malfunctions.
The most frequently reported specific device problem is “Unsealed Device Packaging” (31 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Unsealed Device Packaging31
- Defective Component12
- Loss of or Failure to Bond9
- Packaging Problem9
- Device Packaging Compromised2
- Fluid/Blood Leak2
- Component Missing1
- Detachment of Device or Device Component1
Patient problems
- No Patient Involvement36
- No Clinical Signs, Symptoms or Conditions15
- No Known Impact Or Consequence To Patient7
Recent adverse event reports
The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 23, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER "I WANTED TO GIVE THE PATIENT ANTIBIOTICS VIA THE VENOUS PORT. ABOUT 3 HOURS BEFORE, IT WAS STILL POSSIBLE TO GIVE INFUSIONS WITHOUT ANY PROBLEMS. NOW, HOWEVER, IT WAS NO LONGER POSSIBLE TO EITHER FLUSH OR ASPIRATE BLOOD. BLOOD HAD COLLECTED AT THE FRONT OF THE LINE (AT THE Y-CONNECTION). IN THE END, THE NEEDLE HAD TO BE PULLED OUT. 2 NURSES HAD TRIED TO FLUSH. AFTER THE NEEDLE WAS PULLED OUT, I TRIED TO FLUSH IT AGAIN, IT WAS VERY DIFFICULT AT FIRST, BUT THEN IT WORKED. THERE WAS A RISK OF AN AIR EMBOLISM DUE TO THE LEAK IN THE TUBE. HOWEVER, THE PATIENT SHOWED NO SYMPTOMS OF AN AIR EMBOLISM AND NEVER EXPRESSED ANY COMPLAINTS." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19381105 ↗MalfunctionNov 30, 2023Component Missing; Component Missing
IT WAS REPORTED BY THE CUSTOMER "I WANTED TO PIERCE A PATIENT'S PORT AND PREPARED THE MATERIAL. I UNPACKED THE NEEDLE AND DROPPED IT ON THE STERILE SURFACE FROM THE PACKAGING. WHEN I WENT TO TAKE THE NEEDLE, I SAW THAT THERE WAS NO NEEDLE GUARD. THE PRODUCT WAS NOT USED. SO NO CONSEQUENCES FOR THE PATIENT. UNFORTUNATELY, A SAMPLE WILL NOT BE AVAILABLE AS THE CUSTOMER HAS DISPOSED OF IT ON SITE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18243023 ↗MalfunctionApr 4, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, DURING PREPARATION THE NEEDLE IS DRIPPING AT THE HOSE ATTACHMENT. THERE IS NO IMPACT ON PATIENT, USER, OR THIRD PARTY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16678842 ↗MalfunctionJun 2, 2022Defective Component; Defective Component
IT WAS REPORTED "WITH PORT NEEDLES, THE CLAMP DOESN'T CLOSE PROPERLY, BLOOD FLOW CONTINUES. PATIENT CAN BLEED OUT IF UNNOTICED." IT WAS REPORTED THIS OCCURRED WITH EIGHT DEVICES. THIS REPORT ADDRESSES THE SEVENTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14582214 ↗MalfunctionJun 2, 2022Defective Component; Defective Component
IT WAS REPORTED "WITH PORT NEEDLES, THE CLAMP DOESN'T CLOSE PROPERLY, BLOOD FLOW CONTINUES. PATIENT CAN BLEED OUT IF UNNOTICED." IT WAS REPORTED THIS OCCURRED WITH EIGHT DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14582211 ↗MalfunctionJun 2, 2022Defective Component; Defective Component
IT WAS REPORTED "WITH PORT NEEDLES, THE CLAMP DOESN'T CLOSE PROPERLY, BLOOD FLOW CONTINUES. PATIENT CAN BLEED OUT IF UNNOTICED." IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14582208 ↗MalfunctionJun 2, 2022Defective Component; Defective Component
IT WAS REPORTED "WITH PORT NEEDLES, THE CLAMP DOESN'T CLOSE PROPERLY, BLOOD FLOW CONTINUES. PATIENT CAN BLEED OUT IF UNNOTICED." IT WAS REPORTED THIS OCCURRED WITH EIGHT DEVICES. THIS REPORT ADDRESSES THE FOURTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14582135 ↗MalfunctionJun 2, 2022Defective Component; Defective Component
IT WAS REPORTED "WITH PORT NEEDLES, THE CLAMP DOESN'T CLOSE PROPERLY, BLOOD FLOW CONTINUES. PATIENT CAN BLEED OUT IF UNNOTICED." IT WAS REPORTED THIS OCCURRED WITH EIGHT DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14582127 ↗MalfunctionJun 2, 2022Defective Component; Defective Component
IT WAS REPORTED "WITH PORT NEEDLES, THE CLAMP DOESN'T CLOSE PROPERLY, BLOOD FLOW CONTINUES. PATIENT CAN BLEED OUT IF UNNOTICED." IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14582120 ↗MalfunctionJun 2, 2022Defective Component; Defective Component
IT WAS REPORTED "WITH PORT NEEDLES, THE CLAMP DOESN'T CLOSE PROPERLY, BLOOD FLOW CONTINUES. PATIENT CAN BLEED OUT IF UNNOTICED." IT WAS REPORTED THIS OCCURRED WITH EIGHT DEVICES. THIS REPORT ADDRESSES THE FIFTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14582079 ↗MalfunctionJun 2, 2022Defective Component; Defective Component
IT WAS REPORTED "WITH PORT NEEDLES, THE CLAMP DOESN'T CLOSE PROPERLY, BLOOD FLOW CONTINUES. PATIENT CAN BLEED OUT IF UNNOTICED." IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE FOURTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14582072 ↗MalfunctionJun 2, 2022Defective Component; Defective Component
IT WAS REPORTED "WITH PORT NEEDLES, THE CLAMP DOESN'T CLOSE PROPERLY, BLOOD FLOW CONTINUES. PATIENT CAN BLEED OUT IF UNNOTICED." IT WAS REPORTED THIS OCCURRED WITH EIGHT DEVICES. THIS REPORT ADDRESSES THE SIXTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14582036 ↗MalfunctionJun 2, 2022Defective Component; Defective Component
IT WAS REPORTED "WITH PORT NEEDLES, THE CLAMP DOESN'T CLOSE PROPERLY, BLOOD FLOW CONTINUES. PATIENT CAN BLEED OUT IF UNNOTICED." IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14581979 ↗MalfunctionJun 2, 2022Defective Component; Defective Component
IT WAS REPORTED "WITH PORT NEEDLES, THE CLAMP DOESN'T CLOSE PROPERLY, BLOOD FLOW CONTINUES. PATIENT CAN BLEED OUT IF UNNOTICED." IT WAS REPORTED THIS OCCURRED WITH EIGHT DEVICES. THIS REPORT ADDRESSES THE EIGHTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14581856 ↗MalfunctionJun 2, 2022Defective Component; Defective Component
IT WAS REPORTED "WITH PORT NEEDLES, THE CLAMP DOESN'T CLOSE PROPERLY, BLOOD FLOW CONTINUES. PATIENT CAN BLEED OUT IF UNNOTICED." IT WAS REPORTED THIS OCCURRED WITH EIGHT DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14581819 ↗MalfunctionAug 17, 2018Detachment of Device or Device Component
IT WAS REPORTED THAT THE HUBER NEEDLE WAS REMOVED IN THE CORRECT MANNER AND THE NEEDLE CAME DETACHED FROM THE HUB, THE NEEDLE REMAINED IN PATIENTS PORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7793400 ↗MalfunctionJun 16, 2017Loss of or Failure to Bond; Packaging Problem
IT WAS REPORTED THAT THE PACKAGING WAS NOT COMPLETELY SEALED AROUND THE EDGE. DEVICE WAS NOT USED ON PATIENT. THIS REPORTED ADDRESSES DEVICE FORTY-TWO.
Patient problems: No Patient Involvement
MAUDE report 6648396 ↗MalfunctionJun 16, 2017Unsealed Device Packaging
IT WAS REPORTED THAT THE PACKAGING WAS NOT COMPLETELY SEALED AROUND THE EDGE. DEVICE WAS NOT USED ON PATIENT. THIS REPORTED ADDRESSES DEVICE THIRTY-EIGHT.
Patient problems: No Patient Involvement
MAUDE report 6648394 ↗MalfunctionJun 16, 2017Unsealed Device Packaging
IT WAS REPORTED THAT THE PACKAGING WAS NOT COMPLETELY SEALED AROUND THE EDGE. DEVICE WAS NOT USED ON PATIENT. THIS REPORTED ADDRESSES DEVICE THIRTY-TWO.
Patient problems: No Patient Involvement
MAUDE report 6648388 ↗MalfunctionJun 16, 2017Unsealed Device Packaging
IT WAS REPORTED THAT THE PACKAGING WAS NOT COMPLETELY SEALED AROUND THE EDGE. DEVICE WAS NOT USED ON PATIENT. THIS REPORTED ADDRESSES DEVICE THIRTY.
Patient problems: No Patient Involvement
MAUDE report 6648387 ↗MalfunctionJun 16, 2017Loss of or Failure to Bond; Packaging Problem
IT WAS REPORTED THAT THE PACKAGING WAS NOT COMPLETELY SEALED AROUND THE EDGE. DEVICE WAS NOT USED ON PATIENT. THIS REPORTED ADDRESSES DEVICE FORTY-ONE.
Patient problems: No Patient Involvement
MAUDE report 6648384 ↗MalfunctionJun 16, 2017Unsealed Device Packaging
IT WAS REPORTED THAT THE PACKAGING WAS NOT COMPLETELY SEALED AROUND THE EDGE. DEVICE WAS NOT USED ON PATIENT. THIS REPORTED ADDRESSES DEVICE THIRTY-FIVE.
Patient problems: No Patient Involvement
MAUDE report 6648381 ↗MalfunctionJun 16, 2017Unsealed Device Packaging
IT WAS REPORTED THAT THE PACKAGING WAS NOT COMPLETELY SEALED AROUND THE EDGE. DEVICE WAS NOT USED ON PATIENT. THIS REPORTED ADDRESSES DEVICE THIRTY-NINE.
Patient problems: No Patient Involvement
MAUDE report 6648376 ↗MalfunctionJun 16, 2017Unsealed Device Packaging
IT WAS REPORTED THAT THE PACKAGING WAS NOT COMPLETELY SEALED AROUND THE EDGE. DEVICE WAS NOT USED ON PATIENT. THIS REPORTED ADDRESSES DEVICE FORTY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6648374 ↗MalfunctionJun 16, 2017Unsealed Device Packaging
IT WAS REPORTED THAT THE PACKAGING WAS NOT COMPLETELY SEALED AROUND THE EDGE. DEVICE WAS NOT USED ON PATIENT. THIS REPORTED ADDRESSES DEVICE THIRTY-SEVEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6648373 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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