Port Access Kit 2672010Recalls & reported problems
Bard Access Systems, Inc. · PowerLoc 20G x 1" with Y-Site PAK · Class 2
All models of Port Access Kit (49)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741044540), received between Feb 19, 2020 and Jun 30, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Crack” (2 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.
Most reported problems
Device problems
- Crack2
- Fluid/Blood Leak2
- Activation Problem1
- Detachment of Device or Device Component1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 30, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED BY THE CUSTOMER THAT THE Y-SITE CAP IS EITHER LOOSE OR COMING OFF CREATING EXPOSURE RISKS FOR BOTH THE NURSE AND PATIENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17239701 ↗MalfunctionJun 16, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THE ITEM HAS COME IN DAMAGED. NO OTHER INFORMATION PROVIDED. ADDITIONAL INFORMATION RECEIVED 05/26/2021 "PORT A CATH TUBING WAS LEAKING AT A RANDOM SPOT IN THE TUBING. NEEDED TO DEACCESS PORT AND REACCESS PORT WITH NEW TUBING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12013320 ↗MalfunctionJun 16, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THE ITEM HAS COME IN DAMAGED. ADDITIONAL INFORMATION RECEIVED ON 05/26/2021: "PORT A CATH TUBING WAS LEAKING AT A RANDOM SPOT IN THE TUBING. NEEDED TO DEACCESS PORT AND REACCESS PORT WITH NEW TUBING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12009781 ↗MalfunctionFeb 19, 2020Activation Problem; Activation Problem
IT WAS REPORTED THE SAFETY NEEDLE BROKE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL: "THERE WAS NO PATIENT INJURY. THE DEFECTIVE PRODUCT WAS DISCOVERED ON (B)(6) 2020 WHEN A PICC TEAM NURSE OPENED THE PACKAGE TO ACCESS THE SAFETY NEEDLE, AND FOUND THE ORANGE SAFETY MECHANISM WAS BROKEN BEFORE EVEN TRYING TO USE IT. THANKFULLY, THE NURSE DIDN¿T WOUND HERSELF OR THE PATIENT. "
Patient problems: No Patient Involvement
MAUDE report 9727168 ↗
Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices
- PowerPort M.R.I., Groshong 9808560Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR3 deaths834 reports
- PowerPort ClearVUE 1608062Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR18 deaths571 reports
- PowerPort ClearVUE 5608062Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR31 deaths542 reports
- PowerPort M.R.I., ChronoFlex 1808000Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR19 deaths513 reports
- PowerPort M.R.I., ChronoFlex 1808060Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 recall15 deaths383 reports
- PowerPort M.R.I., Groshong 1808560Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR10 deaths304 reports
- PowerPort M.R.I., ChronoFlex 1829500Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR6 deaths197 reports
- BardPort M.R.I. 0602680Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 deaths179 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 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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