Port Access Needle 0132275Recalls & reported problems
Bard Access Systems, Inc. · PowerLoc Max 22G 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
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741047404), received between Oct 22, 2019 and Sep 16, 2024 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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-2670-2020 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak7
- Break2
- Crack2
- Disconnection2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Consequences Or Impact To Patient6
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE PORT ACCESS NEEDLE POWERLOC MAX 22G X 0.75INCH (REFERENCE NUMBER (B)(4) ) HAD TWO LEAKS BELOW THE Y-SITE ON THE EXTENSION SET OF THE NEEDLE. BOTH WERE ACCESSED FOR 3 DAYS BEFORE THE Y-SITE BEGAN TO BREAK AND LEAK. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20224724 ↗MalfunctionJun 3, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED "THREE PATIENTS HAVE RETURNED TO HAVE THEIR BOTTLE OF CHEMO AND PORT DE-ACCESSED; DRESSINGS APPEARED SLIGHTLY DAMP AND THE CRACKED AREA WAS THEN NOTED. JUST PRIOR TO, THE NURSE TRIED TO FLUSH AND THERE IS A SMALL HOLE THAT ALSO LEAKS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11932017 ↗MalfunctionMay 26, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "THE PATIENT RETURNED TO HAVE THE BOTTLE OF CHEMO AND PORT DE-ACCESSED; DRESSINGS APPEARED SLIGHTLY DAMP AND THE CRACKED AREA WAS THEN NOTED. JUST PRIOR TO, THE NURSE TRIED TO FLUSH AND THERE IS A SMALL HOLE THAT ALSO LEAKS. ADD INFO RCVD 05/17/2021: PORT ACCESS APRIL 28. PORT DE-ACCESSED APRIL 30 WITH DAMP DRESSING. PORT - RIGHT CHEST. CATHETER SECUREMENT: DRESSING/SECURE WITH TAPE AS PER ROUTINE PRACTICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11886896 ↗MalfunctionMay 26, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "THE PATIENT RETURNED TO HAVE THE BOTTLE OF CHEMO AND PORT DE-ACCESSED; DRESSINGS APPEARED SLIGHTLY DAMP AND THE CRACKED AREA WAS THEN NOTED. JUST PRIOR TO, THE NURSE TRIED TO FLUSH AND THERE IS A SMALL HOLE THAT ALSO LEAKS." ADD INFO RCVD: 05/17/2021: PORT ACCESS APRIL 21 PORT DE-ACCESSED APRIL 23 WITH DAMP DRESSING. PORT - RIGHT CHEST. CATHETER SECUREMENT: DRESSING/SECURE WITH TAPE AS PER ROUTINE PRACTICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11886894 ↗MalfunctionJan 29, 2021Break; Break; Disconnection
IT WAS REPORTED THE TUBING BECAME UNATTACHED AT THE HUB CONNECTION LEAVING AN OPEN PATHWAY. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED 01/07/2021: WAS THERE PATIENT HARM REPORTED?: CAUSED RE-ACCESS OF A PEDIATRIC PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11251682 ↗MalfunctionJan 20, 2021Break; Detachment of Device or Device Component; Break
IT WAS REPORTED THE TUBING BECAME UNATTACHED AT THE HUB CONNECTION LEAVING AN OPEN PATHWAY. ADDITIONAL INFORMATION RECEIVED 1/7/2021: IT WAS REPORTED THE PEDIATRIC PATIENT HAD TO BE RE-ACCESSED BUT NO HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11205585 ↗MalfunctionJan 20, 2021Disconnection; Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE TUBING BECAME UNATTACHED AT THE HUB CONNECTION LEAVING AN OPEN PATHWAY. ADDITIONAL INFORMATION RECEIVED 1/7/2021: IT WAS REPORTED THE PEDIATRIC PATIENT HAD TO BE RE-ACCESSED, BUT NO HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11205584 ↗MalfunctionApr 21, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED LEAKING AT THE Y SITE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9983790 ↗MalfunctionApr 21, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED LEAKING AT THE Y SITE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9983788 ↗MalfunctionOct 22, 2019Crack; Crack
IT WAS REPORTED THAT THE FACILITY IS HAVING A LEAKING ISSUE WITH THE HUBER SAFESTEP 22 X ¾¿ NEEDLE. IT WAS STATED THE LEAKING SEEMS TO BE OCCURRING INSIDE THE HUB NOT AT THE CONNECTION POINT. (B)(6) 2019 ADDITIONAL INFORMATION RECEIVED FROM FACILITY STATED, THIS OCCURRED POST CHEMO. THE FRACTURE WAS STATED TO BE RUNNING LENGTH WISE ON HUB AT THE CLOSEST PORT TO THE PATIENT WHERE THEY DRAW LABS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9219656 ↗
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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page