Port Access Needle S02320-75Recalls & reported problems
Bard Access Systems, Inc. · MiniLoc 20G 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
Quick summary
This Bard MiniLoc is a small intravenous catheter used to access veins for infusions and injections. Most of the 38 reports describe fluid or blood leaking from the tubing, connectors, or wings during flushing, and a few describe needles found bent or twisted. There are no deaths, one report of an injury involving air entering the line and a patient briefly feeling short of breath, and 37 malfunction reports. 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
- 38
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00801741048968), received between Oct 10, 2019 and Nov 24, 2025 — classified as 1 injury, 37 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (36 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 Leak36
- Material Deformation2
- Material Twisted/Bent1
Patient problems
- No Consequences Or Impact To Patient31
- No Clinical Signs, Symptoms or Conditions5
- Dyspnea1
- High Blood Pressure/ Hypertension1
- Low Oxygen Saturation1
- Pain1
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 24, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE TIP OF THE HUBER NEEDLE FOUND CROOKED. PATIENT EXPERIENCED PAIN AND BLEEDING DURING INSERTION OF THE CHEMOPORT NEEDLE. PATIENT REPORTED PAIN WHEN USING THE ALTERNATIVE MINILOC WITH INJECTION Y-SITE DURING CHEMOPORT NEEDLE INSERTION. NO OTHER INFORMATION WAS PROVIDED. 11/07/2025: THE RETURNED DEVICE EXHIBITED A BENT NEEDLE.
Patient problems: Pain
MAUDE report 23638071 ↗InjuryJun 2, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation
IT WAS REPORTED, HOLE IN LINE. AIR GOT INTO THE TUBING. PATIENT WAS AFFECTED. PATIENT HAD SUDDEN ONSET SHORTNESS OF BREATH, WHEN PORT WAS FLUSHED. OXYGEN SATURATION DROPPED, AND BP WAS ELEVATED. PATIENT WAS TRANSPORTED VIA EMS TO THE HOSPITAL. SHE WAS DISCHARGED HOME ON (B)(6) 2025. NO FURTHER ISSUES. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Dyspnea; High Blood Pressure/ Hypertension; Low Oxygen Saturation
MAUDE report 22126497 ↗MalfunctionApr 2, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED DURING INJECTION OF PHYSIOLOGICAL SERUM, WHEN THE CANULA WAS INSERTED, THE LIQUID CAME OUT THROUGH THE WINGS. NEEDLE REMOVED AND NEW NEEDLE INSERTED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21755373 ↗MalfunctionSep 30, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT WHEN FLUSHING THE MINILOCK ITS LEAKING FROM THE YELLOW BUTTERFLY CONNECTOR BY THE TUBING. NO OTHER INFORMATION PROVIDED, AT THIS TIME. IT WAS REPORTED THAT THIS HAS HAPPENED 6 TIMES WHEN FLUSHING THE MINILOC. THIS REPORT ADDRESSES ALL 6 DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20334305 ↗MalfunctionMar 7, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THEY HAD TWO NEEDLES WITH BLOOD SHOOTING BACK. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18857111 ↗MalfunctionMar 7, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THEY HAD TWO NEEDLES WITH BLOOD SHOOTING BACK. ADDITIONAL INFORMATION RECEIVED ON 01-APR-2024: THERE WERE NO HEALTH CONSEQUENCES TO PATIENTS. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18856898 ↗MalfunctionNov 1, 2022Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED BY THE CUSTOMER "NEEDLE HAS BENT WHILE IN THE PATIENT." NO OTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15712606 ↗MalfunctionMay 20, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE MINILOC LEAKED FROM MEDEGEN PORT DURING USE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10074437 ↗MalfunctionApr 7, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE RN WAS ATTEMPTING TO DRAW BLOOD FROM THE DISTAL PORT AND BLOOD WAS EXPELLED FROM THE PROXIMAL PORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9933233 ↗MalfunctionMar 19, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED WHEN THEY PULL THE NEEDLES OUT OF THE PACKAGING, THE TUBING TOWARDS THE DISTAL END IS FALLING OFF WHERE THE Y-SITE TUBING ATTACHES. IT WAS REPORTED THIS OCCURRED WITH FIVE DEVICES. THIS REPORT ADDRESSES THE THIRD OF FIVE DEVICES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9856703 ↗MalfunctionMar 19, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED WHEN THEY PULL THE NEEDLES OUT OF THE PACKAGING, THE TUBING TOWARDS THE DISTAL END END IS FALLING OFF WHERE THE Y-SITE TUBING ATTACHES. IT WAS REPORTED THIS OCCURRED WITH FIVE DEVICES. THIS REPORT ADDRESSES THE FOURTH OF FIVE DEVICES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9856702 ↗MalfunctionMar 19, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED WHEN THEY PULL THE NEEDLES OUT OF THE PACKAGING, THE TUBING TOWARDS THE DISTAL END IS FALLING OFF WHERE THE Y-SITE TUBING ATTACHES. IT WAS REPORTED THIS OCCURRED WITH FIVE DEVICES. THIS REPORT ADDRESSES THE FIFTH OF FIVE DEVICES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9856701 ↗MalfunctionMar 19, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED WHEN THEY PULL THE NEEDLES OUT OF THE PACKAGING, THE TUBING TOWARDS THE DISTAL END IS FALLING OFF WHERE THE Y-SITE TUBING ATTACHES. IT WAS REPORTED THIS OCCURRED WITH FIVE DEVICES. THIS REPORT ADDRESSES THE SECOND OF FIVE DEVICES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9856620 ↗MalfunctionMar 19, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED WHEN THEY PULL THE NEEDLES OUT OF THE PACKAGING, THE TUBING TOWARDS THE DISTAL END IS FALLING OFF WHERE THE Y-SITE TUBING ATTACHES. IT WAS REPORTED THIS OCCURRED WITH FIVE DEVICES. THIS REPORT ADDRESSES THE FIRST OF FIVE DEVICES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9856217 ↗MalfunctionNov 20, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE PORT AT THE Y-SITE WITH THE MEDEGEN CONNECTOR WAS LEAKING DURING BLOOD DRAWS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9350612 ↗MalfunctionNov 6, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE Y-SITE ON FOUR NEEDLES LEAKED. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE THIRD NEEDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9287900 ↗MalfunctionNov 6, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE Y-SITE ON FOUR NEEDLES LEAKED. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FOURTH NEEDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9287899 ↗MalfunctionNov 6, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE Y-SITE ON FOUR NEEDLES LEAKED. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND NEEDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9287897 ↗MalfunctionNov 6, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE Y-SITE ON FOUR NEEDLES LEAKED. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST NEEDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9287893 ↗MalfunctionNov 1, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE NURSE WAS ACCESSING THE PORT AND HAVING TROUBLE WITH GETTING ANY FLOW. THEY HAVE REPORTED THAT THE NURSE WILL ¿TROUBLESHOOT¿ WHEN THIS HAPPENS BY PUSHING AND PULLING ON THE PLUNGER OF THEIR SYRINGE, WHICH IS ATTACHED TO THE DISTIL END OF THE HUBER. EITHER AT THIS POINT OR WHEN THEY ARE PULLING THE SYRINGE PLUNGER BACK TO BEGIN THEIR BLOOD DRAW IS WHEN THEY SEE FLUID (OFTEN TIMES BLOOD) COMING OUT OF THE MEDEGEN SEPTUM AT THE Y-SITE. THEY HAVE REPORTED THAT THE BLOOD HAS BEEN ¿SQUIRTING¿ OUT HERE AND THAT THE Y-SITE LEAKS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9266435 ↗MalfunctionOct 23, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT TWO NEEDLES WERE LEAKING FROM THE BLUE Y-SITE VALVE. THIS REPORT ADDRESSES THE SECOND NEEDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9225644 ↗MalfunctionOct 23, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT TWO NEEDLES WERE LEAKING FROM THE BLUE Y-SITE VALVE. THIS REPORT ADDRESSES THE FIRST NEEDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9225635 ↗MalfunctionOct 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE MINILOC W/ Y-SITE WAS FOUND TO BE "DEFECTIVE". (B)(6) 2019: ADDITIONAL INFORMATION REC'D STATES THAT THE PORT NEEDLE IS LEAKING FROM THE SEPTUM ON THE NEEDLELESS VALVE ON THE Y-SITE. IT SEEMS TO BE HAPPENING WHEN NURSES ARE DRAWING BLOOD FROM A PORT AND BLOOD LEAKS OUT OF THE SEPTUM OF THE Y-SITE VALVE. IT WAS STATED THIS HAS OCCURRED WITH 16 DEVICES. THIS REPORT ADDRESSES THE SIXTEENTH DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9176987 ↗MalfunctionOct 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE MINILOC W/ Y-SITE WAS FOUND TO BE "DEFECTIVE". ON 9/24/2019: ADDITIONAL INFORMATION REC'D STATES THAT THE PORT NEEDLE IS LEAKING FROM THE SEPTUM ON THE NEEDLELESS VALVE ON THE Y-SITE. IT SEEMS TO BE HAPPENING WHEN NURSES ARE DRAWING BLOOD FROM A PORT AND BLOOD LEAKS OUT OF THE SEPTUM OF THE Y-SITE VALVE. IT WAS STATED THIS HAS OCCURRED WITH 16 DEVICES. THIS REPORT ADDRESSES THE FIFTEENTH DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9176979 ↗MalfunctionOct 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE MINILOC W/ Y-SITE WAS FOUND TO BE "DEFECTIVE". (B)(6) 2019: ADDITIONAL INFORMATION REC'D STATES THAT THE PORT NEEDLE IS LEAKING FROM THE SEPTUM ON THE NEEDLELESS VALVE ON THE Y-SITE. IT SEEMS TO BE HAPPENING WHEN NURSES ARE DRAWING BLOOD FROM A PORT AND BLOOD LEAKS OUT OF THE SEPTUM OF THE Y-SITE VALVE. IT WAS STATED THIS HAS OCCURRED WITH 16 DEVICES. THIS REPORT ADDRESSES THE FOURTEENTH DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9176977 ↗
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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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