Plan 1 Health 01.60.70.10Recalls & reported problems
Tidi Products, LLC · Catheter Securement for Bard PICC & CVC, Intended for further processing · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00618125143863), received between Mar 15, 2023 and Mar 15, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Material Separation1
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 15, 2023Material Separation; Separation Problem; Material Separation; Separation Problem
IT WAS REPORTED BY PLAN 1 HEALTH, A EUROPEAN IMPORTER, THAT THEY HAD RECEIVED A COMPLAINT FROM THEIR DISTRIBUTOR AND PROVIDED AN IMAGE WITH NO FURTHER DETAILS OF THE COMPLAINT ISSUE. IT APPEARS TO SHOW DELAMINATION OF THE ADHESIVE AND THE ADHESIVE LAYER STUCK TO THE CATHETER HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16545814 ↗
Other Device, Intravascular Catheter Securement devices
- STATLOCK PIC0220Bard Access Systems, Inc. · DEVICE, INTRAVASCULAR CATHETER SECUREMENT47 reports
- STATLOCK CV0220CEBard Access Systems, Inc. · DEVICE, INTRAVASCULAR CATHETER SECUREMENT24 reports
- STATLOCK VPPCSPBard Access Systems, Inc. · DEVICE, INTRAVASCULAR CATHETER SECUREMENT24 reports
- STATLOCK PIC0222Bard Access Systems, Inc. · DEVICE, INTRAVASCULAR CATHETER SECUREMENT18 reports
- STATLOCK VUPD1214Bard Access Systems, Inc. · DEVICE, INTRAVASCULAR CATHETER SECUREMENT13 reports
- Catheter Stabilization Device NG0120C. R. Bard, Inc. · DEVICE, INTRAVASCULAR CATHETER SECUREMENT1 death13 reports
- Grip-Lok 3601CVCTidi Products, LLC · Device, Intravascular Catheter Securement12 reports
- BD PhaSeal™ Optima Infusion Clamp M25-O 515085Becton Dickinson Pen Limited · DEVICE, INTRAVASCULAR CATHETER SECUREMENT12 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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