Port Access Kit 2132075Recalls & reported problems
Bard Access Systems, Inc. · PowerLoc MAX 20G x .75" with Y-Site PAK · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741044205), received between Jul 23, 2024 and Apr 16, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (2 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. How this data works · Data updated Oct 13, 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-2662-2020 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Material Deformation2
- Loss of or Failure to Bond1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2026Loss of or Failure to Bond
CUSTOMER REPORTED THE DRESSING DOES NOT WORK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24901834 ↗MalfunctionJul 23, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT THEY HAD AN ISSUE WITH THE INFUSION NEEDLE SET THAT COMES IN THE BARD 2132075 KIT. THE NEEDLE KIT PORTION ACTUALLY FELL APART, AND THEY OPENED A SECOND ONE AND IT DID THE SAME THING AS WELL. NO HARM TO THE PATIENT, JUST HAD TO ACCESS THE PORT TWICE. THE FIRST ONE HAPPENED AFTER THE PORT ACCESS, THE SECOND KIT THE NEEDLE WAS ALREADY OUT. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19808513 ↗MalfunctionJul 23, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT THEY HAD AN ISSUE WITH THE INFUSION NEEDLE SET THAT COMES IN THE BARD 2132075 KIT. THE NEEDLE KIT PORTION ACTUALLY FELL APART, AND THEY OPENED A SECOND ONE AND IT DID THE SAME THING AS WELL. NO HARM TO THE PATIENT, JUST HAD TO ACCESS THE PORT TWICE. THE FIRST ONE HAPPENED AFTER THE PORT ACCESS, THE SECOND KIT THE NEEDLE WAS ALREADY OUT. THIS REPORT ADDRESSES BOTH INCIDENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19808316 ↗
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page