Statlock Epidural VEDML6Recalls & reported problems
Bard Access Systems, Inc. · StatLock Epidural Micro 6in · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741083235), received between Jun 30, 2022 and Jun 30, 2022 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Restricted Flow rate” (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.
Most reported problems
Device problems
- Restricted Flow rate7
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 30, 2022Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED BY THE CUSTOMER "TUBING IS NOT PRIMING CORRECTLY. PRIMING SHOULD REQUIRE 6CC OF FLUID. HAVE HAD 7 SETS SO FAR WHERE THEY HAVE USED UP TO 17CC AND THERE IS STILL BUBBLING IN THE LINE. LINE JUST DOESN'T PRIME PROPERLY" ADD INFO RCVD: NO CATHETER SECUREMENT DEVICE INVOLVED. PROBLEM IS WITH PRIMING THE SET, SO THEY HAVEN T EVEN GOTTEN AS FAR AS CONNECTING THE PATIENT. THIS REPORT ADDRESSES THE SIXTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14875667 ↗MalfunctionJun 30, 2022Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED BY THE CUSTOMER "TUBING IS NOT PRIMING CORRECTLY. PRIMING SHOULD REQUIRE 6CC OF FLUID. HAVE HAD 7 SETS SO FAR WHERE THEY HAVE USED UP TO 17CC AND THERE IS STILL BUBBLING IN THE LINE. LINE JUST DOESN'T PRIME PROPERLY" ADD INFO RCVD: NO CATHETER SECUREMENT DEVICE INVOLVED. PROBLEM IS WITH PRIMING THE SET, SO THEY HAVEN T EVEN GOTTEN AS FAR AS CONNECTING THE PATIENT. THIS REPORT ADDRESSES THE SEVENTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14875656 ↗MalfunctionJun 30, 2022Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED BY THE CUSTOMER "TUBING IS NOT PRIMING CORRECTLY. PRIMING SHOULD REQUIRE 6CC OF FLUID. HAVE HAD 7 SETS SO FAR WHERE THEY HAVE USED UP TO 17CC AND THERE IS STILL BUBBLING IN THE LINE. LINE JUST DOESN'T PRIME PROPERLY". ADD INFO RCVD: NO CATHETER SECUREMENT DEVICE INVOLVED. PROBLEM IS WITH PRIMING THE SET, SO THEY HAVEN¿T EVEN GOTTEN AS FAR AS CONNECTING THE PATIENT. THIS REPORT ADDRESSES THE FOURTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14875491 ↗MalfunctionJun 30, 2022Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED BY THE CUSTOMER "TUBING IS NOT PRIMING CORRECTLY. PRIMING SHOULD REQUIRE 6CC OF FLUID. HAVE HAD 7 SETS SO FAR WHERE THEY HAVE USED UP TO 17CC AND THERE IS STILL BUBBLING IN THE LINE. LINE JUST DOESN'T PRIME PROPERLY" ADD INFO RCVD: NO CATHETER SECUREMENT DEVICE INVOLVED. PROBLEM IS WITH PRIMING THE SET, SO THEY HAVEN T EVEN GOTTEN AS FAR AS CONNECTING THE PATIENT. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14875482 ↗MalfunctionJun 30, 2022Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED BY THE CUSTOMER "TUBING IS NOT PRIMING CORRECTLY. PRIMING SHOULD REQUIRE 6CC OF FLUID. HAVE HAD 7 SETS SO FAR WHERE THEY HAVE USED UP TO 17CC AND THERE IS STILL BUBBLING IN THE LINE. LINE JUST DOESN'T PRIME PROPERLY" ADD INFO RCVD: NO CATHETER SECUREMENT DEVICE INVOLVED. PROBLEM IS WITH PRIMING THE SET, SO THEY HAVEN T EVEN GOTTEN AS FAR AS CONNECTING THE PATIENT. THIS REPORT ADDRESSES THE THIRD DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14875464 ↗MalfunctionJun 30, 2022Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED BY THE CUSTOMER "TUBING IS NOT PRIMING CORRECTLY. PRIMING SHOULD REQUIRE 6CC OF FLUID. HAVE HAD 7 SETS SO FAR WHERE THEY HAVE USED UP TO 17CC AND THERE IS STILL BUBBLING IN THE LINE. LINE JUST DOESN'T PRIME PROPERLY" ADD INFO RCVD: NO CATHETER SECUREMENT DEVICE INVOLVED. PROBLEM IS WITH PRIMING THE SET, SO THEY HAVEN T EVEN GOTTEN AS FAR AS CONNECTING THE PATIENT. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14875462 ↗MalfunctionJun 30, 2022Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED BY THE CUSTOMER "TUBING IS NOT PRIMING CORRECTLY. PRIMING SHOULD REQUIRE 6CC OF FLUID. HAVE HAD 7 SETS SO FAR WHERE THEY HAVE USED UP TO 17CC AND THERE IS STILL BUBBLING IN THE LINE. LINE JUST DOESN'T PRIME PROPERLY" ADD INFO RCVD: NO CATHETER SECUREMENT DEVICE INVOLVED. PROBLEM IS WITH PRIMING THE SET, SO THEY HAVEN T EVEN GOTTEN AS FAR AS CONNECTING THE PATIENT. THIS REPORT ADDRESSES THE FIFTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14875440 ↗
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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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