Port Access Needle 0132010Recalls & reported problems
Bard Access Systems, Inc. · PowerLoc Max 20G x 1 inch with y-site · Class 2
All models of Port Access Needle (122)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a Bard PowerLoc Max port needle, used to access implanted chemotherapy ports. Reports mostly describe fluid or blood leaking from the tubing and cracks or breaks near the Y-site, with a few caps coming loose or parts detaching. There are 38 reports, with no deaths and no injuries. One recall, started in June 2020 and closed, involved the risk of cracks or breaks in that tubing causing leaks and exposure to chemo drugs or blood.
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
- 37
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00801741047350), received between Apr 11, 2019 and Sep 19, 2024 — classified as 37 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (23 reports).
1 FDA recall record name this device's identifier.
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
Recalls naming this device
- Jun 19, 2020Terminated
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
Z-2670-2020 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak23
- Crack11
- Break3
- Detachment of Device or Device Component3
- Leak/Splash2
- Material Deformation2
- Device Dislodged or Dislocated1
- Fail-Safe Did Not Operate1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- No Consequences Or Impact To Patient6
- No Known Impact Or Consequence To Patient4
- Chemical Exposure1
- Exposure to Body Fluids1
- Insufficient Information1
- Needle Stick/Puncture1
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT THERE WAS A BREAK IN THE HUBER NEEDLE TUBING INTEGRITY AT SITE OF CONNECTION TO BLINA CASSETTE TUBING. THE PATIENT WAS FOUND WITH BLOOD AND FLUID LEAKING FROM THE TUBING. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20258009 ↗MalfunctionJul 2, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT WHILE ACCESSING PATIENT PORT WITH HUBER NEEDLE THE CAP CAME OFF THE Y-SITE. BOTTOM CAP APPLIED TO THE SITE PREVENTING SALINE OR BLOOD FROM SPILLING ON THE PATIENTS. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 6/5/2024: IT WAS REPORTED BY THE CUSTOMER THERE WAS NO PERMANENT HARM. THERE WAS ONE OCCASION THAT CHEMO MAY HAVE BEEN EXPELLED FROM THE LINE AND ON ONE OCCASION THAT BLOOD BACKED UP AND ONTO THE PATIENT AND NURSE. DEVICES WERE DISCARDED. IT WAS REPORTED THIS OCCURRED WITH TWO PATIENTS. THIS REPORT ADDRESSES THE PATIENT THAT HAD BLOOD BACK UP ONTO THEM AND THE NURSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19656985 ↗MalfunctionJun 10, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE PATIENT HAD CHEMOTHERAPY INFUSING OVER APPROXIMATELY 700MLS/HOUR FROM A 100ML SALINE/ CHEMOTHERAPY BAG AND THE CHEMOTHERAPY LEAKED FROM Y-SITE CONNECTION OF POWERLOC MAX. A VERY SMALL AMOUNT APPROXIMATELY 5 DROPS LEAKED OUT. NO HARM TO PATIENT. CHEMOTHERAPY WAS WIPED AND WASHED OFF THE PATIENT¿S SKIN. THE LINE WAS CONNECTED TO THE BOTTOM BUNG. THE LEAKAGE WAS FROM THE TOP BUNG. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Chemical Exposure
MAUDE report 19505746 ↗MalfunctionJun 5, 2024Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation
IT WAS REPORTED THAT WHILE ACCESSING PATIENT PORT WITH HUBER NEEDLE THE CAP CAME OFF THE Y-SITE. BOTTOM CAP APPLIED TO THE SITE PREVENTING SALINE OR BLOOD FROM SPILLING ON THE PATIENTS. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 6/5/2024: IT WAS REPORTED BY THE CUSTOMER THERE WAS NO PERMANENT HARM. THERE WAS ONE OCCASION THAT CHEMO MAY HAVE BEEN EXPELLED FROM THE LINE AND ON ONE OCCASION THAT BLOOD BACKED UP AND ONTO THE PATIENT AND NURSE. DEVICES WERE DISCARDED. IT WAS REPORTED THIS OCCURRED WITH TWO PATIENTS. THIS REPORT ADDRESSES THE PATIENT THAT MAY HAVE HAD CHEMO EXPELLED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19468917 ↗MalfunctionMay 14, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE LEAKING AT Y-SITE CONNECTION OF POWERLOC MAX. THERE WAS NO PATIENT HARM. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19310796 ↗MalfunctionJan 24, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED BY CUSTOMER VIA MEDWATCH, "POWERLOC MAX 20G 1 INCH INSERTED 2023. SUSPECTED LOT ASGZFC004. INSERTED IN PATIENT'S PORT, INFUSING CHEMO, FOUND COMPLETELY SPERATED BEFORE Y-PORT. CHEMO/BLOOD SPILL." ADDITIONAL INFORMATION RECEIVED (B)(6) 2023: PATIENT RECEIVING CHEMO THROUGH A CHEST PORT. THIS RN WALKED INTO THE ROOM AND NOTICED PORT NEEDLE TUBING WAS TORN AT THE FIRST CONNECTION. CHEMO WAS IMMEDIATELY PAUSED. THERE WAS A SMALL AMOUNT OF CHEMO AND BLOOD THAT BACK-FLOWED FROM PORT TUBING ONTO PATIENT'S SHIRT. THE NEEDLE TUBING COULD NOT BE FIXED THEREFORE, PT WAS RE-ACCESSED AND CHEMO WAS RESTARTED. CHEMO PAUSED FOR A TOTAL OF 45 MINUTES. F/U POWER LOC MAX 20G 1 INCH INSERTED (B)(6) 23. FOUND COMPLETELY SEPARATED BEFORE Y-PORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18575705 ↗MalfunctionJan 24, 2024Break; Fluid/Blood Leak; Detachment of Device or Device Component; Break; Fluid/Blood Leak; Detachment of Device or Device Component
IT WAS REPORTED BY CUSTOMER VIA MEDWATCH, "POWERLOC MAX 20G 1 INCH INSERTED 2023. POSSIBLE LOT ASGZFC004. INSERTED IN PATIENT'S PORT, CHEMO INFUSING, FOUND COMPLETELY SEPARATED BEFORE Y PORT. CHEMO AND BLOOD SPILL. THIS IS THE 3RD INCIDENT WITH THIS SAME PRODUCT TYPE/LOT IN 24 HOURS. THIS IS THE FIFTEENTH INCIDENT YEAR TO DATE THIS UNIT HAS EXPERIENCES AT HOSPITAL. WE NOW STOPPED USING THIS PRODUCT. WE HAVE MADE NUMEROUS REPORTS TO THE MANUFACTURER AND THE FDA REGARDING THE INTEGRITY OF THE Y-PORT CONNECTION ON THIS PRODUCT AND SIGNIFICANT IMPAIRMENT EXISTS. PATIENT RISKS INFECTION, BLOOD LOSS (OPEN LINE), AND LEAKAGE OF INFUSATE (IN THESE CASES IT HAS BEEN CHEMO). " ADDITIONAL INFORMATION RECEIVED 01/16/2024: FOUND COMPLETELY SEPARATED BEFORE Y-PORT. FOLLOWUP: PRODUCT REMOVED AND SWAPPED FOR POWER LOC (NO SIDE PORT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18575049 ↗MalfunctionJan 24, 2024Break; Fluid/Blood Leak; Detachment of Device or Device Component; Break; Fluid/Blood Leak; Detachment of Device or Device Component
IT WAS REPORTED VIA MEDWATCH "POWERLOC MAX 20G 1INCH INSERTED (B)(6) 2023 POSSIBLE LOT ASGFC004. FOUND COMPLETELY SEPARATED BEFORE Y-PORT. LOT # ASGZFC004" ADDITIONAL INFORMATION RECEIVED 1/16/2024: IT WAS REPORTED BY THE CUSTOMER DEVICE INSERTED (B)(6) 2023 AND FOUND BROKEN THE NEXT DAY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18573775 ↗MalfunctionDec 22, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT WITHIN THE LAST 96 HOURS, ONE PATIENT HAD 3 BROKEN POWERLOC MAX 20G X 1IN NEEDLES. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE THIRD DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18388710 ↗MalfunctionDec 22, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT WITHIN THE LAST 96 HOURS, ONE PATIENT HAD 3 BROKEN POWERLOC MAX 20G X 1IN NEEDLES. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18384170 ↗MalfunctionDec 22, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT WITHIN THE LAST 96 HOURS, ONE PATIENT HAD 3 BROKEN POWERLOC MAX 20G X 1IN NEEDLES. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18383476 ↗MalfunctionAug 16, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT LEAKING WAS NOTIFIED ON POWERLOC MAX Y SITE NEEDLE AT THE Y SIDE. NO HARM TO PATIENT OR NURSE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17558103 ↗MalfunctionJun 22, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT THERE WAS A BROKEN TUBING/CRACK THAT CAUSED EXTERNAL SPRAY INTO THE FACE OF THE PATIENT WHILE ATTEMPTING TO FLUSH YESTERDAY MORNING.THE LEAK WAS DISCOVERED ON 5/31. THE PORT WAS PLACED ON 5/27 AND WAS INVESTIGATED AND CHANGED IN IR LAST EVENING. PATIENT RECEIVED PRBC, ROUTINE 0.9NS FLUSH
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17183385 ↗MalfunctionMay 31, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED VISIBLY CRACKED AND LEAKING ON Y-SITE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 17035302 ↗MalfunctionMay 15, 2023Crack; Crack
CUSTOMER RETURNED A SAMPLE WITH A NOTE STATING IT WAS USED TO ACCESS A PORT ON (B)(6) 2023 AND CRACKED ON (B)(6) 2023. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16936001 ↗MalfunctionApr 14, 2023Crack; Crack
IT WAS REPORTED "PORT ACCESS NEEDLE CRACKED UP THE SIDE OF THE Y-SITE AT THE SEAM. IT IS HARD TO SEE IF YOU ARE NOT ACTIVELY FLUSHING THE PORT. THIS HAS HAPPENED MORE THAN ONCE AND THE PATIENT THIS INCIDENT OCCURRED ON HAD TO BE ACCESSED THREE TIMES BECAUSE TWO PORT ACCESS NEEDLES CRACKED." THIS REPORT ADDRESSES THE FIRST CRACKED NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16746923 ↗MalfunctionApr 14, 2023Crack; Crack
IT WAS REPORTED "PORT ACCESS NEEDLE CRACKED UP THE SIDE OF THE Y-SITE AT THE SEAM. IT IS HARD TO SEE IF YOU ARE NOT ACTIVELY FLUSHING THE PORT. THIS HAS HAPPENED MORE THAN ONCE AND THE PATIENT THIS INCIDENT OCCURRED ON HAD TO BE ACCESSED THREE TIMES BECAUSE TWO PORT ACCESS NEEDLES CRACKED." THIS REPORT ADDRESSES THE SECOND CRACKED NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16746709 ↗MalfunctionMar 22, 2023Crack; Crack
IT WAS REPORTED BY THE CUSTOMER "A LEAKING HUBER NEEDLE IN THE MICU. THERE WAS LR (LACTATED RINGERS) INFUSING THROUGH THE NEEDLE. THE LEAK OCCURRED AT THE Y-SITE." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16590427 ↗MalfunctionFeb 3, 2023Crack; Crack
IT WAS REPORTED BY THE CUSTOMER THAT THE POWERLOC MAX HUBER NEEDLE'S Y-SITE HUB ARE CRACKING. THE INCIDENT DELAYED PATIENT CARE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16296590 ↗MalfunctionFeb 2, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT THE POWERLOC MAX HUBER NEEDLE'S Y-SITE HUB ARE CRACKING. THE INCIDENT DELAYED PATIENT CARE. IT WAS STATED THEY USE THE POWERLOC MAX NEEDLES WITH A B. BRAUN CARESITE NEEDLESS CONNECTOR. THE SPECIFIC NUMBER OF AFFECTED DEVICES WAS NOT PROVIDED BY THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16286891 ↗MalfunctionNov 29, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER "THE HUBER NEEDLE CRACKING AT THE Y SITE WHERE IT IS LUER LOCKED ON".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15881480 ↗MalfunctionNov 9, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED UNIT HAS BEEN HAD ISSUE WITH PORT NEEDLE LINE CRACKING. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15763884 ↗MalfunctionMay 26, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED "HUBER NEEDLE LUER LOCK HUB IS CRACKING. IT APPEARS WHEN THE ADAPTER IS TIGHTENED DOWN IT CRACKS THE SECOND HUB PORT." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14519988 ↗MalfunctionApr 1, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "THERE WAS A NURSE THAT IDENTIFIED A PORT THAT WAS LEAKING AFTER IT WAS PLACED ON A PATIENT ON THURSDAY (B)(6). NO HARM WAS DONE. THE NURSE BELIEVES THERE IS A NICK IN THE TUBING. I DID FLUSH SOME SALINE THROUGH THE TUBING AND DID NOT SEE ANYTHING".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13976909 ↗MalfunctionJun 24, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "HUBER NEEDLE CRACKED WHILE GIVING MEDS THROUGH TUBING WITH SYRINGE." NO OTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12059662 ↗
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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 · each recall links to the FDA recall notice
- 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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