Port Access Needle 8652034Recalls & reported problems
Bard Access Systems, Inc. · PowerLoc 20G x 0.75 inch · Class 2
All models of Port Access Needle (122)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Bard Access Port Access Needle is an intravenous needle set used to deliver fluids. Its 406 adverse event reports often describe fluid leaking at connections, and some describe damaged packaging or cracked parts. The reports include no deaths and 5 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 402
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 402 adverse event reports that list this exact device (DI 00801741048333), received between Jan 30, 2020 and Sep 30, 2026 — classified as 4 injuries, 398 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (243 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
- Fluid/Blood Leak243
- Activation Problem39
- Tear, Rip or Hole in Device Packaging21
- Component Missing18
- Detachment of Device or Device Component17
- Crack15
- Contamination /Decontamination Problem14
- Defective Component13
Patient problems
- No Clinical Signs, Symptoms or Conditions355
- No Consequences Or Impact To Patient14
- No Patient Involvement7
- Pain6
- Discomfort4
- Needle Stick/Puncture4
- Swelling/ Edema4
- Distress2
Recent adverse event reports
The 25 most recent of 402 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953976 ↗MalfunctionSep 23, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873044 ↗MalfunctionSep 23, 2026Fluid/Blood Leak
It was reported the patient was receiving infusion therapy using an implanted port access needle on (b)(6). The catheter was flushed and locked daily according to standard procedures. On August 4, leakage was observed at the infusion connector during administration. The connector was replaced; however, leakage persisted. Further observation determined that the issue was not with the connector itself, but rather a crack at the needle hub/connector area. As a result, infusion could not be continued, and the implanted port access needle was removed. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870559 ↗MalfunctionSep 23, 2026Fluid/Blood Leak
It was reported a chest wall infusion cannula was implanted in the patient. After changing the dressing, an indwelling cannula for the implantable drug delivery system was inserted. Backflow was observed upon suction, the cannula was flushed and found to be unobstructed, and the fluid began to drip smoothly. The system functioned normally for four consecutive days. On the fifth day, while administering the infusion, the nurse noticed a crack in the tubing connected to the infusion cannula. Flushing revealed a leak, rendering the system inoperable. The infusion cannula was removed, and a new drug delivery system was inserted via a new puncture site.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870556 ↗MalfunctionSep 22, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861491 ↗MalfunctionSep 21, 2026Fluid/Blood Leak
It was reported that on (b)(6) 2026, in accordance with the physician¿s orders, a single-use implantable drug delivery device with an indwelling cannula was used to administer an IV infusion to the patient. During use, it was discovered that the cannula hub had fractured and become loose. Use was immediately discontinued, and a new drug delivery device was used to treat the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846049 ↗MalfunctionSep 15, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778977 ↗MalfunctionSep 11, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50733263 ↗MalfunctionSep 10, 2026Fluid/Blood Leak
It was reported on (b)(6) 2026, the Department of Gastroenterology reported the following: A leak was detected in the tubing connecting the single use implantable drug delivery device to the single use implantable drug delivery device¿s indwelling cannula. The device was promptly replaced, and no adverse consequences resulted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718571 ↗MalfunctionSep 10, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718567 ↗MalfunctionSep 10, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50716235 ↗MalfunctionSep 10, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50716233 ↗MalfunctionSep 10, 2026Fluid/Blood Leak
It was reported a single use implantable drug delivery device with a port needle was connected to the patient on (b)(6). On (b)(6), during an infusion, fluid leakage was detected at the connection point between the port needle and the tubing; a new port needle was replaced and used for puncture.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50716231 ↗MalfunctionSep 9, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700891 ↗MalfunctionSep 9, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700876 ↗MalfunctionSep 9, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50698872 ↗MalfunctionSep 9, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50693891 ↗MalfunctionSep 9, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50693888 ↗MalfunctionSep 9, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50693885 ↗MalfunctionAug 19, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50324524 ↗MalfunctionAug 18, 2026Crack; Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50311059 ↗MalfunctionAug 14, 2026Crack; Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50253248 ↗MalfunctionAug 12, 2026Crack; Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50221859 ↗MalfunctionJul 29, 2026Crack; Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50072944 ↗MalfunctionJul 1, 2026Fluid/Blood Leak
IT WAS REPORTED ON (B)(6) 2026, WHILE A NURSE WAS PREPARING TO ADMINISTER AN IV INFUSION USING A DISPOSABLE IMPLANTABLE DRUG DELIVERY DEVICE CANNULA (INSERTED BY THE INTRAVENOUS THERAPY SPECIALIST ON (B)(6) 2026), FLUID LEAKAGE WAS DETECTED IN THE NEEDLE CANNULA TUBING. AFTER REPLACING THE POSITIVE PRESSURE CONNECTOR, LEAKAGE PERSISTED. UPON FURTHER INSPECTION, IT WAS DETERMINED THAT THE LEAK WAS OCCURRING AT THE CONNECTION POINT BETWEEN THE CANNULA AND THE NEEDLELESS INJECTION CAP. THE INFUSION WAS SUSPENDED AFTER CONTACTING THE INTRAVENOUS THERAPY TEAM. THE ORIGINAL CANNULA WAS REMOVED THAT SAME DAY, AND A VENOUS THERAPY SPECIALIST CAME TO THE BEDSIDE TO REINSERT THE CANNULA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25679113 ↗
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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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