Statlock IV IV0566Recalls & reported problems
Bard Access Systems, Inc. · StatLock IV Select micro 9in bifurcated with 2 SmartSite 25 box · Class 2
All models of Statlock IV (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741082061), received between Jan 29, 2019 and Jan 11, 2024 — classified as 16 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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 Leak7
- Break5
- Leak/Splash5
- Crack3
- Detachment of Device or Device Component1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Known Impact Or Consequence To Patient7
- Hemorrhage/Blood Loss/Bleeding1
- No Patient Involvement1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 11, 2024Break; Break
IT WAS REPORTED BY THE CUSTOMER IV TUBING 2 PORT EXTENDING FROM IV CATH IS SPECIFICALLY MALFUNCTIONING WHEN AN IV TUBING IS PULLED ON OR DISLODGED BY THE PATIENT. THIS PATIENT HAD REMOVED ALL OF HIS IVS THIS NIGHT AND EACH ONE HAD MALFUNCTIONED/ BROKE IN THE SAME LOCATION WHICH WAS THE TUBING CONNECTED TO THE END PIECE THAT CONNECTED DIRECTLY TO THE IV CATH THAT WAS INSERTED INTO THE PATIENT. EVENT OCCURRED IN PATIENT ROOM, BUT NO HARM WAS EVIDENT. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED 04 JANUARY 2024: IT WAS REPORTED BY THE CUSTOMER "PRODUCT DISCONNECTED AT HUB AND BLEEDING WAS IDENTIFIED IMMEDIATELY, WITHOUT HARM. EVENT DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION. DEVICE WAS DISCARDED." IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18491293 ↗MalfunctionJan 11, 2024Break; Break
IT WAS REPORTED BY THE CUSTOMER IV TUBING 2 PORT EXTENDING FROM IV CATH IS SPECIFICALLY MALFUNCTIONING WHEN AN IV TUBING IS PULLED ON OR DISLODGED BY THE PATIENT. THIS PATIENT HAD REMOVED ALL OF HIS IVS THIS NIGHT AND EACH ONE HAD MALFUNCTIONED/ BROKE IN THE SAME LOCATION WHICH WAS THE TUBING CONNECTED TO THE END PIECE THAT CONNECTED DIRECTLY TO THE IV CATH THAT WAS INSERTED INTO THE PATIENT. EVENT OCCURRED IN PATIENT ROOM, BUT NO HARM WAS EVIDENT. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED (B)(6). 2024: IT WAS REPORTED BY THE CUSTOMER "PRODUCT DISCONNECTED AT HUB AND BLEEDING WAS IDENTIFIED IMMEDIATELY, WITHOUT HARM. EVENT DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION. DEVICE WAS DISCARDED." IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18491283 ↗MalfunctionJan 10, 2024Break; Break
IT WAS REPORTED THAT, "THE IV EXTENSION TUBING BROKE AT THE HUB BETWEEN THE IV CATHETER AND THE INFUSION PORTS. PATIENT WAS RECEIVING HEPARIN SO THERE WAS A SCANT ABOUT OF BLOOD LOSS FROM THE DISCONNECT THANKFULLY IT WAS CAUGHT FAST ENOUGH BY RN. BODILY OR PSYCHOLOGICAL INJURY RESULTING IN MINIMAL SYMPTOMS, LOSS OF FUNCTION, INJURY LIMITED TO ADDITIONAL TREATMENT, MONITORING, AND/OR INCREASED LENGTH OF STAY." ADDITIONAL INFORMATION RECEIVED: COMPLETELY BROKEN INTO 2 PIECES.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18490348 ↗MalfunctionMar 24, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "LEAKAGE". NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13892414 ↗MalfunctionJan 27, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "I HAVE NOTICED THAT IN THE LAST FEW WEEKS I HAVE HAD LEAKING I.V. TUBING. THIS HAS HAPPENED AT LEAST 4 TIMES ON OUR UNIT. THE PRODUCT IS THE IV Y TUBING #38528. EVERY TIME THE LEAK HAS BEEN IN THE SAME SPOT: THE SECOND CONNECTION FROM THE Y JUNCTION TOWARD THE WHITE HUB. THERE ARE 2 SIDES THAT ARE EXACTLY THE SAME AND GENERALLY ONE SIDE HAS BEEN LEAKING." THIS REPORT ADDRESSES THE THIRD DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13367224 ↗MalfunctionJan 27, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "I HAVE NOTICED THAT IN THE LAST FEW WEEKS I HAVE HAD LEAKING I.V. TUBING. THIS HAS HAPPENED AT LEAST 4 TIMES ON OUR UNIT. THE PRODUCT IS THE IV Y TUBING #38528. EVERY TIME THE LEAK HAS BEEN IN THE SAME SPOT: THE SECOND CONNECTION FROM THE Y JUNCTION TOWARD THE WHITE HUB. THERE ARE 2 SIDES THAT ARE EXACTLY THE SAME AND GENERALLY ONE SIDE HAS BEEN LEAKING." THIS REPORT ADDRESSES THE FOURTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13367221 ↗MalfunctionJan 27, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "I HAVE NOTICED THAT IN THE LAST FEW WEEKS I HAVE HAD LEAKING I.V. TUBING. THIS HAS HAPPENED AT LEAST 4 TIMES ON OUR UNIT. THE PRODUCT IS THE IV Y TUBING #38528. EVERY TIME THE LEAK HAS BEEN IN THE SAME SPOT: THE SECOND CONNECTION FROM THE Y JUNCTION TOWARD THE WHITE HUB. THERE ARE 2 SIDES THAT ARE EXACTLY THE SAME AND GENERALLY ONE SIDE HAS BEEN LEAKING." THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13367208 ↗MalfunctionJan 27, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "I HAVE NOTICED THAT IN THE LAST FEW WEEKS I HAVE HAD LEAKING I.V. TUBING. THIS HAS HAPPENED AT LEAST 4 TIMES ON OUR UNIT. THE PRODUCT IS THE IV Y TUBING #38528. EVERY TIME THE LEAK HAS BEEN IN THE SAME SPOT: THE SECOND CONNECTION FROM THE Y JUNCTION TOWARD THE WHITE HUB. THERE ARE 2 SIDES THAT ARE EXACTLY THE SAME AND GENERALLY ONE SIDE HAS BEEN LEAKING." THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13367170 ↗MalfunctionDec 12, 2020Break
IT WAS REPORTED THE RN WAS STARTING A NEW LINE AND WHEN SHE WENT TO PRE-FLUSH THE EXTENSION TUBING, ONE OF THE Y-SITES BROKE OFF AT THE CONNECTION. THE TUBING HAD NOT YET BEEN CONNECTED TO THE PATIENT.
Patient problems: No Patient Involvement
MAUDE report 10995000 ↗MalfunctionMay 2, 2019Break; Fluid/Blood Leak; Detachment of Device or Device Component
IT WAS REPORTED THE EXTENSION AT THE Y POINT OF THE STATLOCK DEVICE BROKE COMPLETELY AWAY FROM THE BODY OF THE DEVICE. IT WAS STATED, "THE INFUSION TUBING AT THAT POINT FELL TO THE FLOOR AND WE WERE UNABLE TO COMPLETE THE PATIENT¿S THERAPY. THE DEVICE WAS LEAKING AT THAT CONNECTION POINT BEFORE IT BROKE OFF COMPLETELY. WE TRIED TO REDRESS THE IV WITH A NEW DEVICE AND DRESSING BUT WERE UNABLE TO KEEP THE IV LINE IN PLACE. THE PATIENT LOST APPROXIMATELY 20% OF THE DRUG AND DECLINED A NEW IV START. "
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8574960 ↗MalfunctionApr 19, 2019Leak/Splash
IT WAS REPORTED THAT THE MICROBORE EXTENSION SETS ARE LEAKING AT THE Y-SITE WHERE THE TWO LINES SPLIT. IT WAS STATED THIS HAPPENED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8533361 ↗MalfunctionApr 19, 2019Leak/Splash
IT WAS REPORTED THAT THE MICROBORE EXTENSION SETS ARE LEAKING AT THE Y-SITE WHERE THE TWO LINES SPLIT. IT WAS STATED THIS HAPPENED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8533343 ↗MalfunctionApr 17, 2019Leak/Splash; Material Split, Cut or Torn
IT WAS REPORTED THAT THE MICROBORE EXTENSION SETS ARE LEAKING AT THE Y-SITE WHERE THE TWO LINES SPLIT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8524699 ↗MalfunctionJan 29, 2019Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE STATLOCKS APPEAR TO BE CRACKED/LEAKING AT THE "Y" SITE EVEN THOUGH THEY ARE CLAMPED OFF. THIS REPORT ADDRESSES THE FIRST OF THREE DEVICES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8286083 ↗MalfunctionJan 29, 2019Crack; Leak/Splash
IT WAS REPORTED THAT THE STATLOCKS APPEAR TO BE CRACKED/LEAKING AT THE "Y" SITE EVEN THOUGH THEY ARE CLAMPED OFF. THIS REPORT ADDRESSES THE THIRD OF THREE DEVICES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8285751 ↗MalfunctionJan 29, 2019Crack; Leak/Splash
IT WAS REPORTED THAT THE STATLOCKS APPEAR TO BE CRACKED/LEAKING AT THE "Y" SITE EVEN THOUGH THEY ARE CLAMPED OFF. THIS REPORT ADDRESSES THE SECOND OF THREE DEVICES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8285734 ↗
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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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