Port Access Needle 0632234Recalls & reported problems
Bard Access Systems, Inc. · MiniLoc 22G 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
- 21
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00801741047602), received between Oct 3, 2017 and Apr 2, 2026 — classified as 21 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (16 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 Leak16
- Material Deformation2
- Break1
- Flushing Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- No Consequences Or Impact To Patient4
- Insufficient Information3
- No Information1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2026Fluid/Blood Leak
IT WAS REPORTED VIA MEDSUN THAT THE PATIENT SAID "I AM LEAKING" UPON INVESTIGATION THE BD MINILOC SAFETY INFUSION SET WAS LEAKING AT THE CONNECTION SITE TO INFUSION. STOPPED THE INFUSION. TRIED FLUSHING. THIS DID NOT SOLVE THE PROBLEM, REMOVED THE NEEDLE, RE-ACCESSED PATIENT WITH NEW NEEDLE AND CAP. THIS SOLVED THE LEAK. ON-GOING ISSUE WITH THIS DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767374 ↗MalfunctionMar 19, 2026
PATIENT SAID, "I AM LEAKING" UPON INVESTIGATION THE BD MINILOC SAFETY INFUSION SET WAS LEAKING AT THE CONNECTION SITE TO INFUSION. STOPPED THE INFUSION. TRIED FLUSHING. THIS DID NOT SOLVE THE PROBLEM, REMOVED THE NEEDLE, RE-ACCESSED PATIENT WITH NEW NEEDLE AND CAP. THIS SOLVED THE LEAK. ON-GOING ISSUE WITH THIS DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24638095 ↗MalfunctionMar 3, 2026Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT WHILE USING THE MINILOC SAFETY INFUSION SET, SPECIFICALLY WITH THE BLUE PLASTIC END PART THAT SCREWS ONTO THE CLAVE, THEY NOTICED WHEN THEY WERE RUNNING A SALINE INFUSION THAT THERE WAS A LEAK WHERE THE INFUSION SET CONNECTS WITH THE CLAVE. AFTER TRYING SEVERAL CLAVES WITH DIFFERENT LOT NUMBERS, THE PROBLEM PERSISTED. A NEW INFUSION SET FROM THE SAME LOT WAS USED AND THE PROBLEM CONTINUED. THEN THEY USED A CLAVE FROM ONE OF THE LOTS THEY HAD TRIED BUT CHANGED TO AN INFUSION SET FROM A DIFFERENT LOT AND THAT FINALLY FIXED THE ISSUE. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24498054 ↗MalfunctionDec 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT LEAKING AT THE CONNECTION SITE TO INFUSION. WE HAD TO RE-ACCESS PATIENT WITH A DIFFERENT NEEDLE. NO FURTHER DETAILS AVAILABLE OR PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23848745 ↗MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT PATIENT WAS RECEIVING CHEMOTHERAPY WHEN THE CATHETER THAT ATTACHES TO THE PORT NEEDLE BEGAN TO LEAK. NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23833596 ↗MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT PATIENT WAS RECEIVING CHEMOTHERAPY WHEN THE CATHETER THAT ATTACHES TO THE PORT NEEDLE BEGAN TO LEAK. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23832800 ↗MalfunctionDec 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
ADDITIONAL INFORMATION PROVIDED ON 17-DEC-2025: WE HAD TO RE-ACCESS PATIENT WITH A DIFFERENT NEEDLE. CHEMOTHERAPY INFUSING AT THE TIME OF EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23820962 ↗MalfunctionDec 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING LEUCOVORIN INFUSION, PATIENT NOTIFIED RN OF SMALL WET DROPS ON HER SHIRT. RNS FLUSHED SEVERAL TIMES AND FURTHER FLUSHING REVEALED LEAKING FROM THE HUBER NEEDLE TUBING. NO HARM REACHED PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23819195 ↗MalfunctionDec 9, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED PATIENT PUT CALL LIGHT ON TO NOTIFY RN THAT HER SHIRT HAD WET AREAS (SMALL DROPS). THIS WAS DURING LEUCOVORIN INFUSION SO NOT CHEMO. DETERMINED TO BE FROM HUBER NEEDLE CONNECTION. CAP AND EQUASHIELD CHANGED. RNS FLUSHED SEVERAL TIMES AND LEAKING SEEMED RESOLVED BUT FURTHER FLUSHING REVEALED LEAKING FROM HUBER NEEDLE TUBING. NEEDLE REMOVED AND PATIENT HAD TO BE RE-ACCESSED WITH NEW SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23759209 ↗MalfunctionOct 29, 2025Break; Break
IT WAS REPORTED BY A CUSTOMER THAT THE LINE WAS BROKEN AT CONNECTION FROM PORT LINE TO CAP. PATIENT HARM WAS REPORTED. NO FURTHER DETAILS AVAILABLE OR PROVIDED.
Patient problems: Insufficient Information
MAUDE report 23418549 ↗MalfunctionOct 29, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE LINE WAS BROKEN AT CONNECTION FROM PORT LINE TO CAP. PATIENT HARM WAS REPORTED. NO FURTHER DETAILS AVAILABLE OR PROVIDED.
Patient problems: Insufficient Information
MAUDE report 23415221 ↗MalfunctionJun 20, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED PHYSICIAN UTILIZING A MINILOC NEEDLE ON A PATIENT REPORTED LEAKING FROM THE NEEDLE. NEEDLE WAS CHANGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22302257 ↗MalfunctionJun 17, 2025Material Deformation; Material Deformation
IT WAS REPORTED BY THE CUSTOMER THE SPIN COLLAR IS VERY STIFF AND DOES NOT SPIN FREELY. THE CONNECTOR DOES NOT SECURELY FIT THE MINILOC. STAFF REPORT IT "POPPING OFF" AND THEN BLEEDING VIA THE CATHETER ON TO BED LINES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22243416 ↗MalfunctionMay 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT CENTRAL LINE FOUND LEAKING, UPON INSPECTION IVAD NEEDLE FOUND TO HAVE A CRACK IN THE LINE, NEAR THE CAP BUT NOT AT THE CAP. PATIENT DOES PULL ON LINES AND MOVES AROUND IN BED A LOT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22031932 ↗MalfunctionJan 15, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT WHILE PATIENT INFUSING, PORT NEEDLE LINE BROKE BELOW WHERE THE BUNG IS. HAD BLOOD AND FLUIDS LEAKING FROM THIS, WAS CLAMPED THEN DE-ACCESSED AND RE-ACCESSED WITH NEW NEEDLE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18515311 ↗MalfunctionOct 4, 2022Material Deformation; Material Deformation
IT WAS REPORTED VIA MEDWATCH "AFTER ACCESSING PATIENT'S IMPLANTED PORT USING MINILOC 22G 3/4IN NEEDLE, I DREW LABS PER PROTOCOL. WHILE CLEANING END OF LINE WITH ALCOHOL SWAB, THE SWAB GOT CAUGHT ON SOMETHING SHARP. I NOTICED A SHARD OF PLASTIC WAS HANGING OFF THE END OF THE LINE. IT WAS STILL ATTACHED TO PRODUCT AND DID NOT DISLODGE. PT DID NOT EXPERIENCE ANY HARM FROM DEFECTED PRODUCT. I DEACCESSED PT'S PORT AND THREW PRODUCT AWAY BUT KEPT ORIGINAL PACKAGING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15540501 ↗MalfunctionJul 10, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED PATIENT REPORTS MINILOC TUBING PULLED OUT OF NEEDLE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10258485 ↗MalfunctionJun 24, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "PT. USES MINILOC 0632234 TO ACCESS HER POWERPORT ISP. SHE HAS LOT # ASDUF027 WHERE THE TUBING SPLIT APPROXIMATELY 1.5¿ FROM THE HUB. THIS IS THE THIRD NEEDLE FROM THIS LOT THAT HAS FAILED. SHE GETS 2 BAGS OF SALINE PER DAY, AND 4 IV MEDICATIONS. SHE CONFIRMED A BLOOD RETURN AND DID NOT FEEL RESISTANCE WHEN SHE INFUSED." THIS REPORT ADDRESSES THE THIRD NEEDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10189476 ↗MalfunctionJun 24, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "PT. USES MINILOC 0632234 TO ACCESS HER POWERPORT ISP. SHE HAS LOT # ASDUF027 WHERE THE TUBING SPLIT APPROXIMATELY 1.5¿ FROM THE HUB. THIS IS THE THIRD NEEDLE FROM THIS LOT THAT HAS FAILED. SHE GETS 2 BAGS OF SALINE PER DAY, AND 4 IV MEDICATIONS. SHE CONFIRMED A BLOOD RETURN AND DID NOT FEEL RESISTANCE WHEN SHE INFUSED." THIS REPORT ADDRESSES THE SECOND NEEDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10189472 ↗MalfunctionJun 24, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "PT. USES MINILOC 0632234 TO ACCESS HER POWERPORT ISP. SHE HAS LOT # ASDUF027 WHERE THE TUBING SPLIT APPROXIMATELY 1.5¿ FROM THE HUB. THIS IS THE THIRD NEEDLE FROM THIS LOT THAT HAS FAILED. SHE GETS 2 BAGS OF SALINE PER DAY, AND 4 IV MEDICATIONS. SHE CONFIRMED A BLOOD RETURN AND DID NOT FEEL RESISTANCE WHEN SHE INFUSED." THIS REPORT ADDRESSES THE FIRST NEEDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10189377 ↗MalfunctionOct 3, 2017Flushing Problem
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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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