Port Access Needle 0652234Recalls & reported problems
Bard Access Systems, Inc. · PowerLoc 22G x 0.75 inch · Class 2
All models of Port Access Needle (122)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741047794), received between Dec 7, 2017 and Mar 11, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break2
- Detachment of Device or Device Component1
- Device Operates Differently Than Expected1
- Leak/Splash1
- Moisture or Humidity Problem1
- Particulates1
Patient problems
- No Known Impact Or Consequence To Patient4
- No Clinical Signs, Symptoms or Conditions1
- No Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THE PORT LINE BROKE ABOVE THE POSITIVE PRESSURE CAP. PATIENT ARRIVED TO CLINIC. FATHER REPORTED THAT PORT LINE BROKE ABOVE THE POSITIVE PRESSURE CAP. BLINA WAS INFUSING AND FATHER PAUSED PUMP AT 10:15AM AFTER LINE BROKEN. NO BLOOD FROM CATHETER, ALLIGATOR CLAMP APPLIED BY RN UPON ARRIVAL TO CLINIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21580025 ↗MalfunctionJun 11, 2019Particulates
IT WAS REPORTED THAT THERE WAS A BLACK HAIR FOUND IN THE UNOPENED PACKAGE. THE DEVICE WAS NOT USED ON A PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8689160 ↗MalfunctionApr 25, 2019Leak/Splash
IT WAS REPORTED THAT THE SAFESTEP NEEDLE WAS NOTED TO BE LEAKING. THE NEEDLE WAS EXCHANGED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8549055 ↗MalfunctionMay 24, 2018Moisture or Humidity Problem
IT WAS REPORTED THAT THE CLINICIAN FOUND FLUID/CONDENSATION IN THE TUBING BEFORE IT WAS USED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7541213 ↗MalfunctionMay 24, 2018Break
IT WAS REPORTED THAT THE NEEDLE BROKE DURING THE PORT ACCESS PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7541137 ↗MalfunctionDec 7, 2017Device Operates Differently Than Expected
POWERLOC INFUSION SET WOULD NOT FLUSH PROPERLY WHEN PRIMING.
Patient problems: No Information
MAUDE report 7094937 ↗
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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
- 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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