V-LINK/VITALSHIELD 6N8378Recalls & reported problems
Baxter International Inc. · V-LINK, Non-DEHP Catheter Extension Set, Luer Activated Device with VITALSHIELD Protective Coating, Male Luer Lock Adapter with Retractable Collar · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00085412088341), received between Mar 16, 2018 and Aug 24, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (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
- Connection Problem1
- Fluid/Blood Leak1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2018Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A V-LINK EXTENSION SET LEAKED AT THE DISTAL END OF THE V-LINK CONNECTION TO THE CATHETER. IT WAS REPORTED THAT THE LEAK OCCURRED DURING USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7813957 ↗MalfunctionMar 16, 2018Connection Problem; Connection Problem
IT WAS REPORTED THAT THERE WAS CONNECTION DIFFICULTY WITH TWO (2) V-LINK CATHETER EXTENSION SETS. THIS ISSUE OCCURRED DURING SETUP WITH PATIENT INVOLVEMENT. THE RETRACTABLE COLLAR ON THE SET DEVICE WOULD NOT MOVE FORWARD TO CONNECT ON THE TUBING. WHEN THE END USER REMOVED THE COVER TO CONNECT TO PATIENT THROUGH A CATHETER TUBING, THE LUER LOCK ON THE DEVICE WAS OBSERVED TO BE STUCK IN ITS RETRACTED POSITION, AND WOULD NOT ADVANCE FORWARD TO SECURE ON TO THE CATHETER AT THE DISTAL END OF THE TUBING. THERE WAS NO DAMAGE OR ISSUES FOUND ON THE PRODUCT PRIOR TO USING IT. THE ISSUE WAS RESOLVED, AS THEY WERE ABLE TO USE ANOTHER SET AND MAKE THE CONNECTION AND CONTINUE THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7345332 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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