Port Access Needle 012001NYRecalls & reported problems
Bard Access Systems, Inc. · HuberPlus 20G x 1" with Y-Site and Needless Injection Site · Class 2
All models of Port Access Needle (122)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Bard HuberPlus needle set is used to access implanted ports for chemotherapy and other infusions. Most of the 64 reports describe leaking at the needle or its Y-connector during flushing, along with needles bending or deforming on insertion and some cracking. One report describes a needle fragment left in a patient, and one injury was reported; no deaths. No recalls name this device, and no new reports came in during the past 12 months.
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
- 64
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00801741065569), received between Aug 31, 2018 and Jan 28, 2025 — classified as 1 injury, 63 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (38 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak38
- Material Deformation35
- Leak/Splash6
- Crack3
- Tear, Rip or Hole in Device Packaging2
- Defective Component1
- Manufacturing, Packaging or Shipping Problem1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- No Patient Involvement13
- No Known Impact Or Consequence To Patient10
- No Consequences Or Impact To Patient2
- Discomfort1
- Foreign Body In Patient1
- Pain1
- Vomiting1
Recent adverse event reports
The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 28, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER, THE END USER AT CHEMO DEPARTMENT NOTICED THAT THERE IS LEAKAGE AT THE Y-SYTE OF THE CHEMOPORT DURING FLUSHING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21260939 ↗MalfunctionOct 19, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation
IT WAS REPORTED THERE WAS NEEDLE LEAKAGE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15632973 ↗MalfunctionOct 18, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation
IT WAS REPORTED THERE WAS NEEDLE LEAKAGE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15629157 ↗MalfunctionAug 26, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT NURSE OPENED A HUBER PLUS AND CHECKED PATENCY. WHEN FLUSHED WITH HEPARINIZED SALINE FROM THE MAIN HUB, THERE WAS LEAKING FROM Y-CONNECTOR HUB. NURSE KEPT THE DEFECTIVE NEEDLE AND OPENED A NEW BOX OF HUBER PLUS TO CONTINUE TREATMENT. PATIENT STATUS/ INTERVENTION: CANCER PATIENT IS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15303464 ↗MalfunctionJul 8, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT NURSE ACCESSED CHEMOPORT WITH HUBER PLUS AND FLUSHED WITH NORMAL SALINE FROM THE MAIN HUB. THERE WAS LEAKING FROM Y-CONNECTOR HUB. NURSE DE-ACCESSED CHEMOPORT AND OPENED A NEW BOX OF HUBER PLUS TO CONTINUE TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14962248 ↗MalfunctionJul 8, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT NURSE ACCESSED CHEMOPORT WITH HUBER PLUS AND FLUSHED WITH NORMAL SALINE FROM THE MAIN HUB. THERE WAS LEAKING FROM Y-CONNECTOR HUB. NURSE DE-ACCESSED CHEMOPORT AND OPENED A NEW BOX OF HUBER PLUS TO CONTINUE TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14962159 ↗MalfunctionJun 9, 2022Material Deformation; Material Deformation
IT WAS REPORTED "HUBER PLUS NEEDLE SAFETY SET 20G X 1.0 IN WITH NEEDLESS Y-SITE ISSUES OF THE NEEDLE BENDING ON INSERTION." ADDITIONAL INFORMATION RECEIVED: DATE OF OCCURRENCE: (B)(6) 2022, PATIENT INFORMATION (IF AVAILABLE) - WAS THERE ANY PATIENT HARM REPORTED? IF YES, PLEASE DESCRIBE THE HARM, HOW IT WAS TREATED AND THE OUTCOME. NO ¿ PATIENT REQUIRED A SECOND ACCESS. (B)(6) 2022 - THE NEEDLE TIP WAS BARBED AND THE SAFETY COULD NOT BE ADVANCED PAST THE BENT REGION ON THE RETURNED DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14650702 ↗MalfunctionApr 1, 2022Material Deformation; Material Deformation
IT WAS REPORTED NO BACK FLOW WHEN ASPIRATING. ON (B)(6) 2022- THREE DEVICES WERE RETURNED FOR EVALUATION. ALL THREE DEVICES LEAKED. THIS REPORT ADDRESSES THE THIRD DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13978765 ↗MalfunctionApr 1, 2022Material Deformation; Material Deformation
IT WAS REPORTED NO BACK FLOW WHEN ASPIRATING. ON (B)(6) 2022 THREE DEVICES WERE RETURNED FOR EVALUATION. ALL THREE DEVICES LEAKED. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13978754 ↗MalfunctionApr 1, 2022Material Deformation; Material Deformation
IT WAS REPORTED NO BACK FLOW WHEN ASPIRATING. ON (B)(6) 2022 THREE DEVICES WERE RETURNED FOR EVALUATION. ALL THREE DEVICES LEAKED. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13978752 ↗MalfunctionMar 31, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT CANCER PATIENT BOUGHT HUBER PLUS FROM PHARMACY AND BROUGHT TO THE ONCOLOGY UNIT. STAFF NURSE OPENED THE HUBER PLUS AND PRIME THE NEEDLE FROM MAIN HUB BUT DID NOT PRIME FROM Y-SITE. SHE INSERTED NEEDLE TO CHEMOPORT AND CONNECTED LUER LOCK SYRINGE CONTAINED 10ML OF NORMAL SALINE TO MAIN HUB. SHE INFUSED WITH 10ML NORMAL SALINE AND SAW SALINE LEAKED AND SPILLED FROM Y-SITE. SHE STOPPED THE PROCEDURE AND INFORMED HEAD OF NURSE IMMEDIATELY. ONCOLOGY STAFF NURSE OPENED A NEW HUBER PLUS NEEDLE THAT BOUGHT BY PATIENT AND IT HAD THE SAME LEAKAGE PROBLEM. ONCOLOGY STAFF NURSE OPENED ANOTHER HUBER PLUS NEEDLE BOUGHT BY PATIENT TO CONTINUE PROCEDURE. CANCER PATIENT IS FINE. THIS REPORT ADDRESSES THE SECOND NEEDLE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13967588 ↗MalfunctionMar 31, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation
IT WAS REPORTED THAT CANCER PATIENT BOUGHT HUBER PLUS FROM PHARMACY AND BROUGHT TO THE ONCOLOGY UNIT. STAFF NURSE OPENED THE HUBER PLUS AND PRIME THE NEEDLE FROM MAIN HUB BUT DID NOT PRIME FROM Y-SITE. SHE INSERTED NEEDLE TO CHEMOPORT AND CONNECTED LUER LOCK SYRINGE CONTAINED 10ML OF NORMAL SALINE TO MAIN HUB. SHE INFUSED WITH 10ML NORMAL SALINE AND SAW SALINE LEAKED AND SPILLED FROM Y-SITE. SHE STOPPED THE PROCEDURE AND INFORMED HEAD OF NURSE IMMEDIATELY. ONCOLOGY STAFF NURSE OPENED A NEW HUBER PLUS NEEDLE THAT BOUGHT BY PATIENT AND IT HAD THE SAME LEAKAGE PROBLEM. ONCOLOGY STAFF NURSE OPENED ANOTHER HUBER PLUS NEEDLE BOUGHT BY PATIENT TO CONTINUE PROCEDURE. CANCER PATIENT IS FINE. THIS REPORT ADDRESSES THE FIRST NEEDLE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13967566 ↗MalfunctionFeb 1, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation
IT WAS REPORTED LEAKAGE FROM Y SITE CONNECTOR WHEN PERFORMING FLUSHING PRIOR TO USE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13419396 ↗MalfunctionJan 27, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT STAFF NURSE PRIMED THIS HUBER PLUS WITH 5ML HEPARINIZED SALINE FROM MAIN HUB AND IT WAS IN GOOD CONDITION. SHE INSERTED HUBER NEEDLE TO CHEMOPORT WITH 10ML HEPARINIZED SALINE SYRINGE CONNECTED TO MAIN HUB, TO CHECK BLOOD RETURN AND TO FLUSH. SHE REALIZED THERE WAS A LEAKAGE AT THE Y CONNECTOR WHILE FLUSHING. SHE ASPIRATED AIR AND NO BLOOD RETURN FROM MAIN HUB. SHE REMOVED HUBER NEEDLES. CANCER PATIENT IS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13372820 ↗MalfunctionJan 20, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation
IT WAS REPORTED THAT CANCER PATIENT BOUGHT HUBER PLUS FROM PHARMACY IN THIS HOSPITAL AND BROUGHT TO FACILITY. STAFF NURSE INSERTED NEEDLE TO CHEMOPORT AND CONNECTED LUER LOCK SYRINGE CONTAINED 10ML OF NORMAL SALINE TO MAIN HUB, NORMAL SALINE LEAKED AND SPILLED FROM Y-SITE, ONCE SHE INFUSED. SHE STOPPED THE PROCEDURE AND INFORMED MEDICAL OFFICER IN-CHARGED. CANCER PATIENT IS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13310921 ↗MalfunctionJan 20, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation
IT WAS REPORTED THAT CANCER PATIENT BOUGHT HUBER PLUS FROM PHARMACY IN THIS HOSPITAL AND BROUGHT TO DAYCARE ONCOLOGY UNIT. STAFF NURSE INSERTED NEEDLE TO CHEMOPORT AND CONNECTED LUER LOCK SYRINGE CONTAINED 10ML OF NORMAL SALINE TO MAIN HUB, ASPIRATED TO CHECK BLOOD RETURN. HOWEVER, NORMAL SALINE LEAKED AND SPILLED FROM Y-SITE, ONCE SHE INFUSED. SHE STOPPED THE PROCEDURE AND INFORMED NURSE MANAGER. NURSE MANAGER REPORTED TO NURSING OFFICER. CANCER PATIENT IS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13308957 ↗MalfunctionJan 20, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation
IT WAS REPORTED THAT DIFFERENT STAFF NURSES PRIME THESE HUBER PLUS WITH 5ML HEPARINIZED SALINE AND REALIZED THERE WERE LEAKAGE AT Y CONNECTORS. IT WAS REPORTED THIS OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13308400 ↗MalfunctionJan 20, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation
IT WAS REPORTED THAT DIFFERENT STAFF NURSES PRIME THESE HUBER PLUS WITH 5ML HEPARINIZED SALINE AND REALIZED THERE WERE LEAKAGE AT Y CONNECTORS. IT WAS REPORTED THIS OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13308314 ↗MalfunctionJan 20, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation
IT WAS REPORTED THAT DIFFERENT STAFF NURSES PRIME THESE HUBER PLUS WITH 5ML HEPARINIZED SALINE AND REALIZED THERE WERE LEAKAGE AT Y CONNECTORS. IT WAS REPORTED THIS OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13308288 ↗MalfunctionJan 20, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation
IT WAS REPORTED THAT "STAFF NURSE PRIME THIS HUBER PLUS WITH 5ML HEPARINIZED SALINE BUT DID NOT REALIZE THERE WAS A LEAK AT CONNECTOR. SHE INSERTED NEEDLE TO CHEMOPORT AND CONNECTED LUER LOCK SYRINGE CONTAINED 10ML OF HEPARINIZED SALINE TO MAIN HUB. SHE ASPIRATED TO CHECK BLOOD RETURN AND LEAKED AND SPILLED FROM Y-SITE, ONCE SHE INFUSED. SHE STOPPED THE PROCEDURE AND INFORMED NURSE MANAGER. CANCER PATIENT IS FINE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13308278 ↗MalfunctionJan 19, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation
IT WAS REPORTED THAT DURING STAFF NURSES PRIME THIS HUBER PLUS WITH 5ML HEPARINIZED SALINE AND REALIZED THERE WAS A LEAKAGE AT THE Y CONNECTOR. SHE INFORMED NURSE MANAGER, WHO COMPLAINED TO VENDOR IMMEDIATELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13299282 ↗MalfunctionDec 23, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT CANCER PATIENT BOUGHT HUBER PLUS FROM PHARMACY IN THIS HOSPITAL AND BROUGHT TO FACILITY. STAFF NURSE OPENED THIS BOX OF HUBER PLUS AND INSERTED NEEDLE TO CHEMOPORT AND CONNECTED LUER LOCK SYRINGE CONTAINED 10ML OF NORMAL SALINE TO MAIN HUB. SHE INFUSED WITH 10ML NORMAL SALINE AND SAW SALINE LEAKED AND SPILLED FROM Y-SITE. SHE STOPPED THE PROCEDURE AND INFORMED HEAD OF NURSE AND PHARMACIST. CANCER PATIENT IS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13078249 ↗MalfunctionDec 22, 2021Fluid/Blood Leak; Tear, Rip or Hole in Device Packaging; Fluid/Blood Leak; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THREE NEEDLES EXHIBITED LEAKAGE FROM Y SITE CONNECTOR. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13061270 ↗MalfunctionDec 22, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THREE NEEDLES EXHIBITED LEAKAGE FROM Y SITE CONNECTOR. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE THIRD DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13061267 ↗MalfunctionDec 22, 2021Fluid/Blood Leak; Tear, Rip or Hole in Device Packaging; Fluid/Blood Leak; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THREE NEEDLES EXHIBITED LEAKAGE FROM Y SITE CONNECTOR. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13061259 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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