Port Access Needle 0652010Recalls & reported problems
Bard Access Systems, Inc. · PowerLoc 20G x 1 inch · Class 2
All models of Port Access Needle (122)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741047749), received between May 21, 2019 and Aug 20, 2024 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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 Leak7
- Restricted Flow rate3
- Crack2
- Activation Problem1
- Detachment of Device or Device Component1
- Labelling, Instructions for Use or Training Problem1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- No Consequences Or Impact To Patient4
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2024Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
IT WAS REPORTED THAT THEY NEED TO VERIFY A PRODUCT'S MRI STATUS AND MRI CONDITIONS. THE PRODUCT IS POWER LOC SAFETY INFUSION SET. THE LABELING INDICATED THE PRODUCT IS MRI CONDITIONAL BUT THE PACKET INSERT DOES NOT SPECIFY THE MRI CONDITIONS. CURRENTLY, THIS PRODUCT INDICATES IT IS MRI CONDITIONAL WITH THE YELLOW MRI TRIANGLE. WITHOUT TO DOCUMENTATIONS OF THE MRI CONDITIONS OUR FACILITY CAN NOT PROCEED WITH A PATIENT'S MRI WITHOUT THIS INFORMATION. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20002708 ↗MalfunctionNov 3, 2023Activation Problem; Activation Problem
IT WAS REPORTED BY CUSTOMER THAT SHOWED US THAT WHEN SHE GOES TO ACTIVATE THE SAFETY ON THE POWERLOC HUBER NEEDLE, IT DOES NOT COMPLETELY CLICK INTO PLACE UNLESS EXTREME FORCE IS USED. IT SEEMS THAT IT HAS BEEN ACTIVATED BUT IF ANY PRESSURE IS APPLIED THE NEEDLE COMES BACK THROUGH THE SAFETY AND COULD STICK SOMEONE. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18067614 ↗MalfunctionDec 23, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER "FLUSH SITE WHEN PULLED BACK SHE GOT 5CC BLOOD AND THE REST WAS AIR. TO DO WASTE. THEN USE STERILE SYRINGE PULLED BACK AND THEN GOT MORE BLOOD BUT AIR AS WELL. DID THIS THREE TIMES AND HAPPEN EVERY TIME. THIRD TIME WAS WITHOUT CLAVE SO THEY RULED OUT THAT THE CLAVE WAS PROBLEM."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16044660 ↗MalfunctionDec 9, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT "NURSE ACCESSED PORT, WHEN FLUSHING FOR THE FIRST TIME, SALINE CAME OUT OF SIDE OF THE DEVICE." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15949308 ↗MalfunctionMay 7, 2022Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED VIA MS&S "CALLER STATES WHILE PERFORMING A CT OR CTA WITH THE PRESSURE SET AT 250 OR 300 THE MED RAD IS REACHING THE MAX PRESSURE WITH THE POWERLOC WHICH IS CAUSING THE RATE TO DECREASE. THE MED RAD IS SET TO AUTOMATICALLY DECREASE IF THE MAX PRESSURE IS MET FOR SAFETY REASONS." ADDITIONAL INFO. RECEIVED 04/13/2022: HIGH PRESSURE LIMITS ON MEDRAD INJECTOR (STELLANT) WHILE PERFORMING A ANGIO EXAM AT 4.5 ML A SEC AT 325 PSI LIMIT. THIS HAS BEEN CONSISTENTLY HAPPENING AT LOW AND HIGH RATES OF INJECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14316468 ↗MalfunctionApr 29, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "I HAVE A HOME HEALTH NURSE WHO COMES TO MY HOME TO ACCESS ME & SHE ACCESSED ME TUESDAY & WHEN I HOOKED UP TO MY PUMP IS STARTED LEAKING OUT MY BANDAGE & SOAKED MY SHIRT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14251636 ↗MalfunctionApr 14, 2022Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED VIA MS&S "CALLER STATES WHILE PERFORMING A CT OR CTA WITH THE PRESSURE SET AT 250 OR 300 THE MED RAD IS REACHING THE MAX PRESSURE WITH THE POWERLOC WHICH IS CAUSING THE RATE TO DECREASE. THE MED RAD IS SET TO AUTOMATICALLY DECREASE IF THE MAX PRESSURE IS MET FOR SAFETY REASONS. HE STATES THEY HAVE USED 2 SEPARATE MED RAD INJECTORS [WITH] DIFFERENT PATIENTS." THIS REPORT ADDRESSES THE SECOND EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14116557 ↗MalfunctionApr 14, 2022Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED VIA MS&S "CALLER STATES WHILE PERFORMING A CT OR CTA WITH THE PRESSURE SET AT 250 OR 300 THE MED RAD IS REACHING THE MAX PRESSURE WITH THE POWERLOC WHICH IS CAUSING THE RATE TO DECREASE. THE MED RAD IS SET TO AUTOMATICALLY DECREASE IF THE MAX PRESSURE IS MET FOR SAFETY REASONS. HE STATES THEY HAVE USED 2 SEPARATE MED RAD INJECTORS [WITH] DIFFERENT PATIENTS." THIS REPORT ADDRESSES THE FIRST EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14116555 ↗MalfunctionJan 20, 2021Crack; Fluid/Blood Leak
IT WAS REPORTED "THERE WAS A SMALL CRACK IN THE PLASTIC PIECE THAT COVERS THE PORT NEEDLE AND WHEN THEY WENT TO FLUSH, THE SALINE SPRAYED OUT OF THE CRACK."ON (B)(6) 2020- THE RETURNED DEVICE LEAKED FROM THE NEEDLE.
Patient problems: No Patient Involvement
MAUDE report 11202568 ↗MalfunctionNov 19, 2020Crack
IT WAS REPORTED THAT THE NEEDLE CRACKED AT THE Y-SITE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10871987 ↗MalfunctionAug 13, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED CHEMO STARTED THROUGH PORT 6ML INFUSED WHEN CALLED IN AND IT HAD LEAKED OUT AT TUBING/CAP CONNECTION. PATIENT HAD TO BE REACCESSED AND PROVIDER TO DECIDE IF CHEMO CONTINUES WITH 10% LOSS OR TO MAKE A NEW DOSE. PRODUCT CONTAINS BLOOD, NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10405210 ↗MalfunctionMar 18, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT WHEN FLUSHING, FLUID LEAKED OUT OF WHERE NEEDLE AND TUBING CONNECT. WHEN ASPIRATING, TINY BUBBLES APPEARED IN SYRINGE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9847435 ↗MalfunctionMar 12, 2020Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT WAS BEING ASSISTED OUT OF BED WHEN THE HUBER NEEDLE SNAPPED OFF BELOW THE CAP. IT WAS STATED THERE WAS A SLIGHT TUG WHILE GETTING THE PATIENT OUT OF BED. THEY WERE ABLE TO IMMEDIATELY DEACCESS THE PATIENT AND THEN REACCESS THE PORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9823416 ↗MalfunctionMay 21, 2019Material Puncture/Hole
IT WAS REPORTED THAT A SMALL HOLE IN THE TUBING UNDER THE NEEDLE WAS OBSERVED WHEN FLUSHING PORT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8629882 ↗
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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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