Port Access Needle 0632034Recalls & reported problems
Bard Access Systems, Inc. · MiniLoc 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 MiniLoc port access needle is a small needle used to reach a vein for infusions. Its 88 reports, with no deaths and 2 injuries, mostly describe fluid or blood leaking at connection points, tubing snapping, and blocked flow. 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
- 87
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 00801741047565), received between Jun 27, 2018 and Jun 16, 2026 — classified as 2 injuries, 85 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (47 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 Leak47
- Break19
- Activation Problem7
- Contamination /Decontamination Problem4
- Detachment of Device or Device Component4
- Crack3
- Device Dislodged or Dislocated3
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions72
- Insufficient Information4
- No Known Impact Or Consequence To Patient3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Chemical Exposure2
- Needle Stick/Puncture2
- Distress1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2026Break
IT WAS REPORTED TUBING SNAPPED WHERE IT CONNECTS TO THE HUB THAT WOULD CONNECT TO THE MICROCLAVE. THIS HAPPENED WITH PATIENT ON HOME BLINATUMOMAB INFUSIONS. PATIENT'S CONTINUOUS INFUSION OF BLINA HAS TO BE PAUSED, PATIENT HAS TO GET RE-ACCESSED AND A NEW BAG OF BLINA HAS TO BE MADE TO RECONNECT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25527694 ↗MalfunctionJun 16, 2026Break
IT WAS REPORTED TUBING SNAPPED WHERE IT CONNECTS TO THE HUB THAT WOULD CONNECT TO THE MICROCLAVE. THIS HAPPENED WITH PATIENT ON HOME BLINATUMOMAB INFUSIONS. PATIENT'S CONTINUOUS INFUSION OF BLINA HAS TO BE PAUSED, PATIENT HAS TO GET RE-ACCESSED AND A NEW BAG OF BLINA HAS TO BE MADE TO RECONNECT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25527693 ↗MalfunctionJun 16, 2026Break
IT WAS REPORTED TUBING SNAPPED WHERE IT CONNECTS TO THE HUB THAT WOULD CONNECT TO THE MICROCLAVE. THIS HAPPENED WITH PATIENT ON HOME BLINATUMOMAB INFUSIONS. PATIENT'S CONTINUOUS INFUSION OF BLINA HAS TO BE PAUSED, PATIENT HAS TO GET RE-ACCESSED AND A NEW BAG OF BLINA HAS TO BE MADE TO RECONNECT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25527691 ↗MalfunctionMay 1, 2026Failure to Infuse
IT WAS REPORTED THAT WHEN USING THE SALINE IN THE DEVICE, THE LIQUID DOES NOT FLOW, AS IF THERE WAS SOMETHING BLOCKING THE PASSAGE OF THE SODIUM CHLORIDE. THERE WAS NO DAMAGE TO THE PATIENT'S HEALTH. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25057240 ↗MalfunctionApr 28, 2026Fluid/Blood Leak
IT WAS REPORTED CLINICAL STAFF OBSERVED LEAKAGE AT THE HUB/CONNECTION POINT DURING USE IN THE INFUSION SETTING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25019150 ↗MalfunctionApr 28, 2026Fluid/Blood Leak
IT WAS REPORTED CLINICAL STAFF OBSERVED LEAKAGE AT THE HUB/CONNECTION POINT DURING USE IN THE INFUSION SETTING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25016518 ↗MalfunctionApr 27, 2026Fluid/Blood Leak
IT WAS REPORTED THAT LEAKING NEEDLE AT THE TIME OF PUNCTURE. THERE WAS NO DAMAGE TO HEALTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25001578 ↗MalfunctionMar 30, 2026Activation Problem
IT WAS REPORTED THAT WHEN THE NURSES EXAMINED THE OTHER NEEDLES IN STOCK THEY FOUND THE NEEDLES ARE NOT FULLY RETRACTING. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24712355 ↗InjuryMar 30, 2026Activation Problem
IT WAS REPORTED, ONCOLOGY NURSE EXPERIENCED A NEEDLE STICK WITH A PORT NEEDLE APPEARING TO BE FAULTY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Needle Stick/Puncture
MAUDE report 24712224 ↗MalfunctionFeb 12, 2026Fluid/Blood Leak
IT WAS REPORTED THAT PORT WAS ACCESSED. DURING FLUSH PROCEDURE, TUBING NOTED TO BE LEAKING (NEAR THE FLUSH, NOT NEAR THE NEEDLE). THE PATIENT'S PORT HAD TO BE DE-ACCESSED AND RE-ACCESSED WITH A NEW NEEDLE. THE ONLY MEDICATION IN THE LINE WAS THE STERILE NS USED TO PRIME THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24323848 ↗MalfunctionJan 23, 2026Fluid/Blood Leak
IT WAS REPORTED, HOLE IN THE CONNECTION BETWEEN THE CIRCUIT AND THE NEEDLE. THERE WAS NO DAMAGE TO THE PATIENT'S HEALTH. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24162542 ↗MalfunctionDec 19, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED TUBING SNAPPED AT THE JUNCTION WHERE THE TUBING IS BONDED TO THE PLASTIC THAT ENGAGES WITH THE CAP. THE PRODUCT BROKE INTO TWO PIECES. PORT WAS ACCESSED (B)(6) 2025 AND WAS BROKEN (B)(6) 2025. THIS EVENT REQUIRED THE PATIENT TO PRESENT TO THE ED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23849661 ↗MalfunctionDec 10, 2025Break; Break
IT WAS REPORTED THAT TUBING SNAPPED NEAR THE CONNECTION TO THE CAP. PORT WAS ACCESSED (B)(6) 2025. PATIENT NEEDED TO PRESENT TO THE EMERGENCY DEPARTMENT. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23768639 ↗MalfunctionDec 9, 2025Break; Break
IT WAS REPORTED THAT THE LINE BROKE. RESULTING IN ADDITIONAL PORT ACCESSES, INABILITY TO FLUSH PORT WHEN RE-ACCESS, NECESSITATING ALTEPLASE. PAUSED IN IV FLUIDS. MEDICATION INFUSED: D5NS, ONDANSETRON, CEFEPIME, FOSAPREPITANT, VANCOMYCIN. NO FURTHER DETAILS AVAILABLE OR PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23763949 ↗MalfunctionNov 24, 2025Break; Break
ADDITIONAL INFORMATION 12/10. PATIENT RECEIVING 4 WEEKS OF BLINATUMOMAB THROUGH A HOME INFUSION PUMP. THEY RETURN EVERY 7 DAYS FOR A NEW PUMP AND PORT DE-ACCESS AND RE-ACCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23639664 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED BY THE CUSTOMER THAT THE PATIENT ACCIDENTALLY PULLED THE PORT-A NEEDLE EXTENSION TUBING DURING SLEEP, CAUSING IT TO BREAK. THE ISSUE WAS DISCOVERED PROMPTLY, AND THE NEEDLE WAS REMOVED IMMEDIATELY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555798 ↗MalfunctionNov 11, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED TUBING CONNECTED TO THE PORT NEEDLE WAS SEVERED EXPOSING PATIENT TO HD DRUG. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23527123 ↗MalfunctionNov 11, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED TUBING CONNECTED TO THE PORT NEEDLE WAS SEVERED EXPOSING PATIENT TO HD DRUG. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23527001 ↗MalfunctionNov 4, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE NEEDLE LEAKED DURING INSTALLATION. THERE WAS NO DAMAGE TO THE PATIENT'S HEALTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23467449 ↗MalfunctionOct 21, 2025Break; Break
IT WAS REPORTED PORT NEEDLE TUBING SEVERED (THE TUBING BONDED TO THE NEEDLE) WHILE IN USE. PATIENT WAS EXPOSED TO HD DRUG. THERE WAS NOTED NON-INTENTIONAL LINE TUGGING WITH THIS EVENT. NO FURTHER INFORMATION WAS PROVIDED. THE ITEM WAS DISPOSED OF AT THE TIME OF THE EVENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23350799 ↗MalfunctionOct 21, 2025Break; Break
IT WAS REPORTED PORT NEEDLE TUBING SEVERED (THE TUBING BONDED TO THE NEEDLE) WHILE IN USE. PATIENT WAS EXPOSED TO HD DRUG. NO FURTHER INFORMATION WAS PROVIDED. THE ITEM WAS DISPOSED OF AT THE TIME OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23350648 ↗MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
ADDITIONAL INFORMATION RECEIVED ON 22OCT2025: THERE WAS NO PATIENT INJURY, BUT DELAY IN CARE AND TRAUMA TO CHILD FOR BEING RE ACCESSED WITH A NEW NEEDLE SO MEDICATION COULD BE RE-STARTED.
Patient problems: Distress; Insufficient Information
MAUDE report 23292473 ↗MalfunctionAug 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT LEAKING AT THE NEEDLE CONNECTION WITH THE PLASTIC BASE DURING THE PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22841917 ↗MalfunctionAug 14, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BREAKAGE/CRACK AT THE CONNECTION POINT OF THE TUBING. LEAKING. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22807046 ↗MalfunctionJul 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED A LEAKING NEEDLE. THE MATERIAL LEAKED AT THE BASE OF THE NEEDLE INSERT WHEN IT WAS FILLED. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22538752 ↗
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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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