Port Access Needle 0132075Recalls & reported problems
Bard Access Systems, Inc. · PowerLoc Max 20G x 0.75 inch with y-site · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Bard PowerLoc Max port access needle appears in 265 adverse event reports, with no deaths and 8 injuries. The reports mostly describe fluid leaks, cracks, and a safety mechanism that is sticky to activate. Reports fell to 10 in the last 12 months from 16 in the year before. One recall, from June 2020 and now closed, concerns cracks or breaks in the tubing near the connectors that could leak chemicals such as chemotherapy drugs or blood.
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
- 260
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 260 adverse event reports that list this exact device (DI 00801741047374), received between Jun 8, 2018 and Aug 5, 2026 — classified as 8 injuries, 252 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (177 reports).
1 FDA recall record name this device's identifier.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Jun 19, 2020Terminated
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
Z-2670-2020 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak177
- Crack112
- Activation Problem19
- Break9
- Detachment of Device or Device Component5
- Restricted Flow rate4
- Adverse Event Without Identified Device or Use Problem2
- Backflow1
Patient problems
- No Clinical Signs, Symptoms or Conditions132
- Chemical Exposure55
- No Consequences Or Impact To Patient32
- Insufficient Information25
- No Known Impact Or Consequence To Patient9
- Pain8
- Needle Stick/Puncture7
- Exposure to Body Fluids4
Recent adverse event reports
The 25 most recent of 260 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2026Detachment of Device or Device Component; Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50144136 ↗InjuryAug 3, 2026Activation Problem
It was reported by customer that needle wouldn't safety correctly. No further details provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50113915 ↗MalfunctionJul 16, 2026Activation Problem
IT WAS REPORTED THAT THERE HAVE BEEN 4-5 INCIDENTS IN THE LAST COUPLE WEEKS WHERE THE SAFETY ON THE HUBER NEEDLES WILL NOT ENGAGE. IT STOPS HALFWAY DOWN THE NEEDLE. NO FURTHER DETAILS PROVIDED. THIS REPORT ADDRESSES ALL INCIDENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25847172 ↗MalfunctionMar 24, 2026Activation Problem
IT WAS REPORTED VIA MEDWATCH REPORT THAT SAFETY LOCK WOULD NOT ENGAGE AS DESIGNED. NO FURTHER DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24675143 ↗InjuryNov 18, 2025Activation Problem; Activation Problem
IT WAS REPORTED BY A NURSE WHEN REMOVING GRIPPER NEEDLE SAFETY LOCK MECHANISM DID NOT FULLY ENGAGE/FAILED AND NEEDLE STRUCK RIGHT INDEX FINGER WITH SHARP. BLOOD LABS WERE TAKEN FROM THE PATIENT AND CLINICIAN; RESULTS ARE CONFIDENTIAL. NO FURTHER INFORMATION AVAILABLE DUE TO CONFIDENTIALITY.
Patient problems: Exposure to Body Fluids; Needle Stick/Puncture
MAUDE report 23584786 ↗MalfunctionSep 11, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, NEEDLE LEAKED DURING IRRIGATION BETWEEN THE NEEDLE STABILIZER AND THE PATIENT'S SKIN. ADDITIONAL INFORMATION RECEIVED ON 08/29/2025: PATIENT TREATMENT HAD TO BE POSTPONED UNTIL THE NEXT DAY. PORT RE-ACCESSED WITH A NEW NEEDLE. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.
Patient problems: Chemical Exposure
MAUDE report 23026797 ↗MalfunctionSep 11, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED; NEEDLE LEAKED DURING IRRIGATION BETWEEN THE NEEDLE STABILIZER AND THE PATIENT'S SKIN. ADDITIONAL INFORMATION RECEIVED 08/29/2025: PATIENT TREATMENT HAD TO BE POSTPONED UNTIL THE NEXT DAY. PORT RE-ACCESSED WITH A NEW NEEDLE. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.
Patient problems: Chemical Exposure
MAUDE report 23026795 ↗MalfunctionSep 2, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, POWERLOC NOTED TO BE LEAKING DURING USE ON A PATIENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22940266 ↗MalfunctionSep 2, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, POWERLOC NOTED TO BE LEAKING DURING USE ON A PATIENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22940186 ↗MalfunctionJun 30, 2025Restricted Flow rate; Material Deformation; Restricted Flow rate; Material Deformation
PORT NEEDLE NOT REACHING ITS MAXIMUM 5MLS/SECOND AT 300PSI. THE CENTARGO BAYER INJECTOR KEEPS PRESSURING OUT AND NOT HOLDING 5MLS. NO PATIENT HARM. THESE PORT NEEDLES WERE BEING TESTED PRIOR TO USE ON PT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22359931 ↗InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE CUSTOMER "WE HAVE HAD 4 PATIENTS WITH PORTS THAT HAVE HAD REDNESS AROUND THEIR PORT SITES. THE REDNESS CLEARED UP AFTER ROUNDS OF ANTIBIOTICS." THIS REPORT ADDRESSES ALL FOUR PATIENTS.
Patient problems: Erythema; Unspecified Infection
MAUDE report 21652698 ↗MalfunctionMar 5, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE CAP ON THE Y SITE CAME OFF. IT LEAKED BLOOD AND SALINE ONTO THE PATIENT. THEY IMMEDIATELY CLAMPED IT ABOVE THE Y SITE. THEN AIR GOT IN THE LINE BELOW THE Y SITE SO THEY REMOVED IT AND PLACED A NEW LINE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21528953 ↗MalfunctionFeb 12, 2025Break; Break
IT WAS REPORTED PORT TUBING BROKE ABOVE FIRST BLUE CLAVE ON CONNECTION OF THE TUBE AND THE HARD HUB CLOSEST TO THE PATIENT. PORT DE-ACCESSED, AND RE-ACCESSED. THE PORT WAS THE 22G 3/4IN THAT WAS USED IN THE OR. PATIENT IS STABLE, NO CHANGES IN CLINICAL STATUS OR VITAL SIGNS. NO INFECTION. THIS WAS A FULL BREAK. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21363419 ↗MalfunctionJan 21, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED PORT ACCESSED AT HOME FOR BLINATUMOMAB INFUSION. PARENTS NOTICED THAT BLOOD WAS LEAKING FROM PORT TUBING. BLOOD HAD BACK FLOWED INTO PORT TUBING AND MED LINE. POSSIBLY LEAKING FROM CONNECTION SITE, COULDN'T TELL FOR SURE. PATIENT CAME TO CLINIC FOR A NEEDLE CHANGE. IT IS UNKNOWN IF ANY ADVERSE EVENT TOOK PLACE DUE TO THIS INCIDENT. THIS PATIENT HAD THIS HAPPEN TWO DIFFERENT TIMES. THIS REPORT ADDRESSES BOTH OCCURRENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21200605 ↗MalfunctionJan 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, RN WAS ATTEMPTING TO FLUSH AND DRAW LABS FROM PATIENT'S PORT THIS MORNING. HOWEVER, WHILE ATTEMPTING TO FLUSH, RN NOTICED THAT THE TUBING ON THE PORT NEEDLE WAS LEAKING AFTER THE CLOSEST CLAMP (BY THE Y IN THE TUBING). THIS RESULTED IN PATIENT GETTING DEACCESSED AND REACCESSED AND DELAYING ANTIBIOTIC DOSES AND LABS. NO PATIENT INJURY. IT WAS REPORTED THIS OCCURRED WITH SIX DEVICES. THIS REPORT ADDRESSES ALL SIX DEVICES. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21184025 ↗MalfunctionJan 6, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT Y SITE OF PORT-NEEDLE WAS LEAKING ON FLUSHING. DISCARDED THE PORT NEEDLE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21079943 ↗MalfunctionDec 19, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE PRODUCT IS LEAKING. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20981619 ↗MalfunctionDec 19, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE PRODUCT IS LEAKING. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20981542 ↗MalfunctionNov 26, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT PICC IS LEAKING AT ONE OF ITS JUNCTIONS. WE ARE AT 4 COPIES OF THIS BATCH THAT HAVE CAUSED CHEMOTHERAPY SPILLS. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES ALL FOUR DEVICES.
Patient problems: Chemical Exposure
MAUDE report 20783453 ↗MalfunctionNov 25, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, LEAKING AT ONE OF THE JUNCTIONS CAUSING CHEMOTHERAPY SPILL. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20773991 ↗MalfunctionNov 20, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT CHEMO LEAK FOUND TO BE COMING FROM PROXIMAL CLAVE ON PORT LINE WHERE CLAVE MEETS THE LINE. CHEMO DC'D AND PORT LINE REMOVED. ABLE TO FLUSH WITH BLOOD RETURN BUT STILL LEAKING AT CLAVE SITE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20739814 ↗MalfunctionOct 18, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT OVER THE PAST FEW WEEKS THERE HAVE BEEN MULTIPLE FAILURES OF THE BD POWER LOC MAX MEDIPORT NEEDLE. THE FAILURES OCCUR IN THE TUBING CAUSING A LEAK. RESULTS IN BOTH DRUG LOSS AND BLOOD EXPOSURE. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH 3 DEVICES. THIS REPORT ADDRESSES ALL 3 DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20482320 ↗MalfunctionOct 11, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, POWERLOC MAX MEDIPORT NEEDLE FAILURE. TUBING LEAK, PATIENT WAS ADMITTED TO BE DE-ACCESSED, THEN RE-ACCESSED AND NEW MED PREPPED AND STARTED. BLINATUMOMAB USED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20431971 ↗MalfunctionOct 4, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT THE BLOOD STARTED SPRAYING OUT OF THE PLASTIC PIECE CLOSE TO THE BASE. EVENT DATE 09-06-2024, EVENT TIME 07:30. OCCURRED IN AMBULATORY AREA. NO HARM TO PATIENT. ACCESSED PATIENT WITH POWER PORT NEEDLE (POWER LOC MAX) LOT # ASHYFC034. AFTER FLUSHING RECEIVED IMMEDIATE BLOOD RETURN, THEN THE BLOOD STARTED SPRAYING OUT OF THE PLASTIC PIECE CLOSE TO THE BASE. PATIENT WAS DE-ACCESSED AND RE-ACCESSED WITH NEW NEEDLE FROM DIFFERENT LOT # WITHOUT ISSUE. ADDITIONAL INFORMATION RECEIVED 13 SEPT 2024: THERE WASN¿T ANY HARM, INJURY, COMPLICATION, OR NEGATIVE OUTCOME TO THE PATIENT AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20375867 ↗MalfunctionSep 26, 2024Activation Problem; Activation Problem
IT WAS REPORTED THAT SAFETY MECHANISM FOR NEEDLE FAILS WHEN ATTEMPTING TO REMOVE GRIPPER. HAS OCCURRED ON TWO SEPARATE OCCASIONS WITH THE SAME LOT NUMBER. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES BOTH DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20311606 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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