Port Access Needle 8672034Recalls & reported problems
Bard Access Systems, Inc. · PowerLoc 20G x 0.75 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 Bard PowerLoc port access needle is used to access implanted ports for IV infusions and chemotherapy. The 33 reports mostly describe leaking — fluid or blood seeping out at the needle or connection point, often after a few days of use — plus cracks, and less often parts coming loose or going missing. Reports mention no deaths and no injuries, and 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00801741048425), received between Jul 31, 2019 and Sep 22, 2026 — classified as 34 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (24 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 Leak24
- Crack10
- Component Missing2
- Detachment of Device or Device Component2
- Material Deformation2
- Activation Problem1
- Break1
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- No Known Impact Or Consequence To Patient2
- Skin Inflammation/ Irritation2
- Chemical Exposure1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862359 ↗MalfunctionJan 7, 2026Crack; Fluid/Blood Leak
ADDITIONAL INFORMATION RECEIVED 01/08: UPON DETECTING LEAKAGE, THE AFFECTED IV SOLUTION WAS IMMEDIATELY DISCONTINUED. NEW, UNCOMPROMISED SOLUTION WAS ADMINISTERED TO CONTINUE THE INFUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23999511 ↗MalfunctionJan 7, 2026Crack; Fluid/Blood Leak
IT WAS REPORTED GENERAL INTERNAL MEDICINE HAD 2 CASES WHERE PORT NEEDLES LEAKED AFTER 3-4 DAYS OF USE. NO FURTHER INFORMATION AVAILABLE OR PROVIDED. IT WAS REPORTED THIS OCCURRED WITH 2 DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23999152 ↗MalfunctionDec 3, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THE RARE DISEASE ONCOLOGY DEPARTMENT IDENTIFIED LEAKAGE FROM SAFETY-TYPE PORT NEEDLES. ONE CASE WAS DISCOVERED ON (B)(6) OCCURRING ON THE THIRD DAY OF INFUSION, ADDRESSED BY REMOVING AND REPLACING THE NEEDLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23705769 ↗MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE MEDICAL ONCOLOGY DEPARTMENT IDENTIFIED ONE CASE OF LEAKAGE FROM A SECURE-TYPE PORT NEEDLE. ON NOVEMBER 16, A NURSE DISCOVERED THE ISSUE WHILE FLUSHING THE LINE ON THE THIRD DAY OF THE PATIENT'S INFUSION AND PROMPTLY REMOVED AND REPLACED THE PORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704952 ↗MalfunctionDec 3, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THE RARE DISEASE ONCOLOGY DEPARTMENT IDENTIFIED LEAKAGE FROM SAFETY-TYPE PORT NEEDLES. WAS IDENTIFIED ON NOVEMBER 17, OCCURRING ON THE SECOND DAY OF INFUSION. ADDRESSED BY REMOVING AND REPLACING THE NEEDLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704951 ↗MalfunctionNov 13, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED LEAKAGE FROM A SAFETY PORT NEEDLE. REPLACED THE INFUSION PORT NEEDLE AND APPLIED A NEW DRESSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23542233 ↗MalfunctionNov 11, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THREE CASES OF SAFE-TYPE PORT NEEDLE LEAKAGE WERE IDENTIFIED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES ALL THREE DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23528161 ↗MalfunctionNov 11, 2025Crack; Product Quality Problem; Crack; Product Quality Problem
IT WAS REPORTED LEAKAGE AT THE CONNECTION POINT BETWEEN THE SAFETY PORT NEEDLE AND THE INFUSION CONNECTOR. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES ALL FOUR DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23526471 ↗MalfunctionSep 12, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BEFORE USE ON THE PATIENT, THE MEDICATION LEAKED FROM THE ORANGE PART LOCATED BETWEEN THE NEEDLE (USED FOR INJECTING THE DRUG) AND THE SHIELD BASE (THE WHITE WING-SHAPED SUPPORT). AS A RESULT, THE PRODUCT WAS NOT USED AND WAS REPLACED WITH A NEW ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23044415 ↗MalfunctionJul 7, 2025Break; Break
IT WAS REPORTED THAT OF PORT NEEDLE EXTENSION TUBING SEPARATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22413601 ↗MalfunctionJul 7, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A HARBOR NEEDLE LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22412677 ↗MalfunctionJul 1, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT ON (B)(6) 2024, WHILE PREPARING TO CONNECT A PATIENT TO AN INFUSION PORT USING A SINGLE-USE IMPLANTABLE DRUG DELIVERY DEVICE INDWELLING NEEDLE, THE NURSE OPENED THE PACKAGE AND REMOVED IT TO FIND THAT ONE SECTION OF THE STRAIGHT TUBE OF THE Y-FORK OF THE DEVICE'S INDWELLING NEEDLE WAS LONGITUDINALLY SPLIT AND UNUSABLE; IT WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22378649 ↗MalfunctionJul 1, 2025Restricted Flow rate; Fluid/Blood Leak; Restricted Flow rate; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT BARD PORT NEEDLE 20G WITH Y SITE NOT REACHING 5MLS/SECOND AT 300PSI. UPON TESTING THE BAYER CENTARGO INJECTOR COULDN'T REACH THE ADVERTISED 5MLS/SEC AND KEPT PRESSURING OUT. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22373232 ↗MalfunctionDec 6, 2024Material Deformation; Material Deformation
IT WAS REPORTED VIA PHONE CALL RECEIVED INFORMING OF A BENT NEEDLE. UPON QUESTIONING, I WAS INFORMED A PATIENT HAS A POWER PORT INSITU, THIS WAS ACCESSED FOR AN ELASTOMERIC INFUSOR AND HE RETURNED TO DAY ONCOLOGY UNIT TO HAVE THE PORT ACCESS NEEDLE FLUSHED AND REMOVED, AS TREATMENT COMPLETED. NURSES HAD TROUBLE REMOVING NEEDLE AS IT APPEARED TO BE "STUCK". NEEDLE EVENTUALLY REMOVED AND SEEN TO BE "BENT". REPORTED WAS NOT BENT UPON INSERTION. INTERVENTIONAL RADIOLOGY INVOLVED AND REPORTED NO FRAGMENTS WERE FOUND. THEY DID NOT CHECK INTEGRITY OF THE SILICON SEPTUM. PATIENT HAS BEEN KNOWN TO PLAY WITH PORT AND TO RE-ACCESS WITHOUT MEDICAL/NURSING HELP IN THE PAST. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20864858 ↗MalfunctionNov 7, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED POWERLOC DEVELOPED A LEAK ON THE SECOND DAY OF USE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20629016 ↗MalfunctionNov 5, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED, 8672034 DEVELOPED A LEAK ON THE SECOND DAY OF USE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20610265 ↗MalfunctionOct 31, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, 8672034 DEVELOPED A LEAK ON THE SECOND DAY OF USE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20584590 ↗MalfunctionOct 30, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED LINE DEVELOPED A LEAK ON THE SECOND DAY OF USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20571482 ↗MalfunctionOct 30, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER, LINE DEVELOPED A LEAK ON THE SECOND DAY OF USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20569817 ↗MalfunctionJun 5, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT ON APRIL 28, 2024, THE PATIENT USED A MICROINJECTION PUMP TO CONTINUOUSLY INJECT CHEMOTHERAPY DRUGS. AT NIGHT, HE FOUND THAT THE CLOTHES AT THE COLLAR WERE DAMP AND THE CHEMOTHERAPY DRUGS WERE LEAKING. HE CHECKED THAT THERE WAS NO PROBLEM WITH THE INFUSION CONNECTOR AND FOUND THAT THE INFUSION PORT NEEDLE WAS LEAKING. AFTER REMOVING THE NEEDLE, THE TEST FOUND THAT THERE WAS WATER LEAKAGE FROM THE SIDE. AFTER MULTIPLE INSPECTIONS, NO OBVIOUS CRACKS WERE FOUND. CHEMOTHERAPY DRUGS IRRITATED THE SKIN. THE INFUSION NEEDLE WAS REPLACED.
Patient problems: Chemical Exposure; Skin Inflammation/ Irritation
MAUDE report 19472808 ↗MalfunctionMay 23, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2024, THE PATIENT FOUND THAT THE CHEMOTHERAPY PUMP WAS LEAKING AT NIGHT, AND THERE WAS NO PROBLEM WITH THE JOINT WHEN CHECKED, AND THE INFUSION PORT NEEDLE WAS FOUND TO BE LEAKING, AND THE TEST FOUND THAT THERE WAS WATER LEAKAGE ON THE SIDE AFTER THE NEEDLE WAS REMOVED. CHEMOTHERAPY DRUGS IRRITATE THE SKIN. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 19385804 ↗MalfunctionMay 25, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED ON (B)(6) 2023, THE PATIENT WAS IN THE TERMINAL STAGE OF MALIGNANT TUMOR AND HAD BEEN GIVEN DRUGS THROUGH THE PORT OF INTRAVENOUS INFUSION FOR A LONG TIME. WHEN CONNECTING THE INDWELLING NEEDLE OF THE DISPOSABLE IMPLANT DRUG DELIVERY DEVICE TODAY, THE NURSE FOUND THAT THE INDWELLING NEEDLE WAS BROKEN AND LEAKING FLUID AT THE INTERFACE. IMMEDIATE REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17007318 ↗MalfunctionApr 22, 2022Component Missing; Component Missing
IT WAS REPORTED THAT THERE WAS NO NEEDLE TIP PROTECTOR INSIDE UPON OPENING OF THE PACKAGE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14189733 ↗MalfunctionApr 22, 2022Component Missing; Component Missing
IT WAS REPORTED THAT THERE WAS NO NEEDLE TIP PROTECTOR INSIDE UPON OPENING OF THE PACKAGE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14189357 ↗
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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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