Port Access Needle 0141910Recalls & reported problems
Bard Access Systems, Inc. · PowerLoc Max 19G 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741047411), received between May 15, 2019 and Feb 3, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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. 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 Leak2
- Device Dislodged or Dislocated1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Chemical Exposure1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2026Device Dislodged or Dislocated
IT WAS REPORTED FREQUENT PROBLEMS WITH THE POWERLOC MAX PORT CANNULA. THESE CAN BE LOCKED IN PLACE WITH THE BASE PLATE, WHICH RESTS ON THE PATIENT'S SKIN. HOWEVER, THIS LOCKING MECHANISM FOR THE RETAINING PLATE IS TOO LOOSE, CAUSING THE PORT NEEDLE TO SLIP OUT OF THE PORT CHAMBER DURING TREATMENT AND ALLOWING THE INFUSION SOLUTION TO LEAK INTO THE SURROUNDING TISSUE. THERE HAVE BEEN NO REPORTS OF ADVERSE EFFECTS FROM PATIENTS OR USERS. AN EXACT NUMBER OF OCCURRENCES HAS NOT BEEN PROVIDED BY THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24251892 ↗MalfunctionJan 5, 2026Fluid/Blood Leak
ADDITIONAL INFORMATION RECEIVED 12/29/2025: NO PATIENT HARM OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23958422 ↗MalfunctionNov 15, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING INFUSION OF CHEMOTHERAPY, LEAKAGE OCCURRED AT THE JUNCTION OF NEEDLE AND PIPE AND CAUSED LEAKAGE OF CHEMOTHERAPY ONTO THE PATIENT'S SKIN. NO OTHER INFORMATION PROVIDED.
Patient problems: Chemical Exposure
MAUDE report 18145730 ↗MalfunctionMay 15, 2019Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED VIA MS&S THAT THERE WAS A HAIR FOUND INSIDE POWERLOC MAX KIT. KIT WAS OPENED, BUT NOT USED ON PATIENT AND REPORTED NO HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8612124 ↗
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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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