Port Access Needle S02020-75Recalls & 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
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741048784), received between Sep 6, 2018 and Mar 20, 2021 — classified as 2 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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.
Most reported problems
Device problems
- Fluid/Blood Leak4
- Activation Problem3
- Leak/Splash3
- Break2
- Contamination /Decontamination Problem2
- Device Contamination with Chemical or Other Material2
- Component Missing1
- Connection Problem1
Patient problems
- No Known Impact Or Consequence To Patient6
- No Consequences Or Impact To Patient5
- No Patient Involvement4
- Burn, Thermal2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE WAS LEAKING DURING ADMINISTRATION OF CYTOSTATICS. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11536701 ↗MalfunctionAug 20, 2020Activation Problem; Activation Problem
IT WAS REPORTED THAT NEEDLE WAS WITH AN ISSUE WITH THE SAFETY LOCK. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10434622 ↗MalfunctionAug 20, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED NEEDLE WITH LEAKAGE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10434588 ↗MalfunctionJul 23, 2020Activation Problem; Activation Problem
IT WAS REPORTED MINILOC NEEDLE WITH LOOSE SAFETY LOCK. DEVICE WAS NOT USED ON A PATIENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 10314939 ↗MalfunctionApr 28, 2020Break; Break
IT WAS REPORTED THAT THE NEEDLE WAS BROKE. ON (B)(6) 2020 - THE RETURNED NEEDLE HAS A BROKEN EXTENSION SET AND ALSO HAD RESIDUE INSIDE THAT DID NOT APPEAR TO BE SALINE CRYSTALS BUT MAY HAVE BEEN INFUSATE CRYSTALS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10006165 ↗MalfunctionMar 24, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED BY THE CUSTOMER DIRT WAS NOTICED ON THE NEEDLE TIP. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9876124 ↗MalfunctionNov 7, 2019Activation Problem; Activation Problem
IT WAS REPORTED THAT THE ORANGE DEVICE CAME OFF AND THE NEEDLE LEFT THE SAFETY BASE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 9290428 ↗MalfunctionNov 6, 2019Defective Component; Material Deformation; Defective Component; Material Deformation
IT WAS REPORTED THAT BEVEL INCLINATION AND BURRS ON THE TIP OF THE NEEDLE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9287355 ↗MalfunctionOct 30, 2019Component Missing; Component Missing
IT WAS INFORMED THE NEEDLE SHIELD WAS MISSING. THE DEVICE WAS NOT USED ON A PATIENT.
Patient problems: No Patient Involvement
MAUDE report 9256115 ↗MalfunctionSep 25, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
CLIENT REPORTS PRESENCE OF FOREIGN BODY AT NEEDLE TIP.
Patient problems: No Patient Involvement
MAUDE report 9120989 ↗MalfunctionJul 10, 2019Device Contamination with Chemical or Other Material
IT WAS REPORTED "BURRS IN THE MINILOC." ON 6/18/2019, PER INVESTIGATION SMALL FOREIGN PARTICLES WERE PRESENT IN THE RETURNED DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8777643 ↗MalfunctionJun 13, 2019Break
IT WAS REPORTED THAT THE SAFETY LOCK WAS BROKEN. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8697381 ↗InjuryMay 22, 2019Fluid/Blood Leak
IT WAS REPORTED THAT THE PATIENT IS COMPLAINING THAT THE GRIPPER IS LEAKING AND BURNED PATIENT. A OF (B)(6) 2019 NO FURTHER REPORTS ON THE CLIENT¿S STATUS HAVE BEEN REPORTED. IT WAS STATED THAT TWO NEEDLES WERE NOTED TO BE LEAKING. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: Burn, Thermal
MAUDE report 8634076 ↗InjuryMay 22, 2019Leak/Splash
IT WAS REPORTED THAT THE PATIENT IS COMPLAINING THAT THE GRIPPER IS LEAKING AND BURNED PATIENT. A OF (B)(6) 2019 NO FURTHER REPORTS ON THE CLIENT¿S STATUS HAVE BEEN REPORTED. IT WAS STATED THAT TWO NEEDLES WERE NOTED TO BE LEAKING. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: Burn, Thermal
MAUDE report 8634060 ↗MalfunctionMar 13, 2019Leak/Splash; Connection Problem
IT WAS REPORTED THAT THE CONNECTION WAS LEAKING ON THE MINILOC NEEDLE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8416381 ↗MalfunctionDec 7, 2018Contamination /Decontamination Problem
IT WAS REPORTED THAT IN THE PRODUCTION LINE, 1 UNIT OF NEEDLE MINILOC LOT ASBVS0051 PRESENTED SOME FLUID/LIQUID IN THE INFUSION LINE. THE UNIT WAS SEGREGATED, IDENTIFIED AND FORWARDED FOR SHIPMENT TO THE MANUFACTURER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8142182 ↗MalfunctionOct 25, 2018Leak/Splash
IT WAS REPORTED THAT MINILOC NEEDLE SHOWED LEAKAGE IN THE CURVATURE OF THE NEEDLE DURING INFUSION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8004963 ↗MalfunctionSep 6, 2018Fluid/Blood Leak
IT WAS REPORTED THAT DURING PUNCTURE THE MINILOC PRESENTED LEAKAGE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7853052 ↗
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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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