STATLOCK VUPD1416Recalls & reported problems
Bard Access Systems, Inc. · SL UNIV PLUS LRG 14-16FR W/SKIN PREP · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741083464), received between Feb 16, 2018 and Dec 9, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED STABILIZATION DEVICE BROKEN OFF ADHESIVE, ALLOWED THE CHEST TUBE TO MOVE 1-1.5 INCHES IN PATIENT. THERE WAS MINIMAL HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23758392 ↗MalfunctionFeb 16, 2018Unsealed Device Packaging
IT WAS REPORTED THAT A VUPD1416 WAS IMPROPERLY PACKAGED AS A FOL0102. THE COMPLAINT ORIGINALLY WENT TO BMD DIVISION AND WAS REPORTED VIA BMDFA QUOTE: "IT WAS REPORTED THAT THE FOL0102 WAS ALLEGEDLY INCORRECTLY PACKAGED IN A VUPD1416 ENVELOPE CAUSING CUSTOMER TO BUY A SECOND VUPD1416 DEVICE. " NO PATIENT INJURY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7278555 ↗
Other DEVICE, INTRAVASCULAR CATHETER SECUREMENT devices
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- STATLOCK CV0220CEBard Access Systems, Inc. · DEVICE, INTRAVASCULAR CATHETER SECUREMENT24 reports
- STATLOCK PIC0222Bard Access Systems, Inc. · DEVICE, INTRAVASCULAR CATHETER SECUREMENT18 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.