Port Access AN142075Recalls & reported problems
Bard Access Systems, Inc. · AllPoints Port Access System PowerLoc Max 20G x 0.75 inch · Class 2
All models of Port Access (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741119224), received between Oct 8, 2019 and Jun 3, 2025 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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-2660-2020 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Dislodged or Dislocated4
- Break1
- Contamination /Decontamination Problem1
- Loss of or Failure to Bond1
- Misassembled1
Patient problems
- No Consequences Or Impact To Patient5
- No Clinical Signs, Symptoms or Conditions2
- Needle Stick/Puncture1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2025Misassembled; Misassembled
IT WAS REPORTED BY THE CUSTOMER THERE WAS NO SLEEVE COVERING THE HUBER NEEDLE. THE HCP SUFFERED A NEEDLE STICK WHILE ATTACHING THE CLAVE AND STERILE FLUSH. THE DEVICE WAS DISPOSED OF AFTER THE EVENT.
Patient problems: Needle Stick/Puncture
MAUDE report 22135077 ↗MalfunctionMar 13, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS A HAIR IN THE PORT ACCESS SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21602146 ↗MalfunctionJun 9, 2021Break; Break
IT WAS REPORTED THAT PART OF THE EXTENSION TUBING WAS SNAPPED OFF AND ON THE BED AT THE END OF THE SHIFT. NOTHING WAS INFUSING THROUGH IT AT THE TIME. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11971141 ↗MalfunctionOct 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PORT NEEDLES HAVE BECOME DISPLACED OR HAVE FALLEN OUT. THIS HAS OCCURRED WHILE CHEMOTHERAPY WAS ACTIVELY BEING INFUSED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9169987 ↗MalfunctionOct 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PORT NEEDLE HAS BECOME DISPLACED OR FALLEN OUT. THIS OCCURRED WHILE CHEMOTHERAPY WAS ACTIVELY BEING INFUSED. IT WAS STATED PATIENT WAS NOT MOVING AT THE TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9169983 ↗MalfunctionOct 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PORT NEEDLE HAS BECOME DISPLACED OR FALLEN OUT. THIS OCCURRED WHILE CHEMOTHERAPY WAS ACTIVELY BEING INFUSED. THE PATIENT¿S TUBING WAS WRAPPED IN HER GOWN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9169980 ↗MalfunctionOct 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PORT NEEDLES HAVE BECOME DISPLACED OR HAVE FALLEN OUT. THIS HAS OCCURRED WHILE CHEMOTHERAPY WAS ACTIVELY BEING INFUSED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9169970 ↗MalfunctionOct 8, 2019Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT "THE DRESSINGS IN THE PORT KITS ARE NOT ADHERING TO INPATIENTS FOR A FULL 7 DAYS. THE DRESSINGS ARE TENTED AND MADE ESPECIALLY FOR PORTS BUT THEY ARE LOOSENING ON THE BORDERS REQUIRING A DRESSING CHANGE. THIS WOULD NOT BE NOTICED BY INFUSION CENTERS WHO USE THE SAME DRESSING BUT DON¿T HAVE LONG TERM ACCESS."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9169967 ↗
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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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