Port Access Needle 0682234Recalls & reported problems
Bard Access Systems, Inc. · MiniLoc 22G 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
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741048081), received between Jun 12, 2019 and Sep 26, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak2
- Crack1
- Leak/Splash1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT WHEN SHE ACCESSES HER POWERPORT WITH THE MINILOC NEEDLE, AFTER FLUSHING WITH SALINE, THE CAP ON THE Y-SITE "FLYS OFF". CALLER CONFIRMS SHE IS NOT TIGHTENING THE CAP PRIOR TO USE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20313101 ↗MalfunctionMar 22, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE PRODUCT CRACKED WHILE BEING PLACED ON PATIENT. ADDITIONAL INFORMATION RECEIVED 03/02/2024: IT WAS REPORTED, "EMPLOYEE CLAMPED THE PORT-A-CATH NEEDLE, CLEANED THE Y SITE LUER LOCK AND THEN FLUSHED THE PORT-A-CATH. EMPLOYEE THEN CONDUCTED PUSH PULL METHOD TO REMOVE WASTE AND THEN OBTAINED BLOOD SAMPLE. EMPLOYEE THEN CLEANED THE Y SITE AND ATTEMPTED TO FLUSH THE Y SITE LUER LOCK WHICH EMPLOYEE DISCOVERED WAS LEAKING FROM THE Y SITE AND LUER LOCK. EMPLOYEE ATTEMPTED TO REPLACE THE LUER LOCK WITH ANOTHER ITEM WITH THE SAME ISSUE. UPON FURTHER INVESTIGATION EMPLOYEE NOTICED THAT THE Y SITE THREAD WAS CRACKED. EMPLOYEE INFORMED PATIENT THAT THE PORT-A-CATH NEEDLE WOULD NEED TO BE REMOVED AND A NEW PORT-A-CATH NEEDLE WOULD NEED TO BE INSERTED." IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18963166 ↗MalfunctionOct 19, 2022Material Deformation; Material Deformation
IT WAS REPORTED BY THE CUSTOMER: "THE TUBING IS EASILY KINKED." WAS THE PRODUCT USED ON A PATIENT? YES WAS THERE ANY PATIENT HARM REPORTED? IF YES, PLEASE DESCRIBE THE HARM, HOW IT WAS TREATED AND THE OUTCOME. NO APPARENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15633343 ↗MalfunctionJun 12, 2019Leak/Splash
IT WAS REPORTED THAT THE MINILOC TUBING "EXPLODED" DURING INJECTION. COMPLAINANT STATED THAT "IT DOESN'T SOUND LIKE ANY HARM CAME FROM THE LEAK".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8692963 ↗
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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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