NA 2C6227Recalls & reported problems
Baxter International Inc. · Extension Set, Male Luer Lock Adapter · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00085412003917), received between Jan 31, 2018 and Nov 17, 2023 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Packaging Problem” (4 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Packaging Problem4
- Crack2
- Detachment of Device or Device Component1
- Disconnection1
- Fluid/Blood Leak1
Patient problems
- No Patient Involvement6
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 17, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
IT WAS REPORTED THAT AN EXTENSION SET LEAKED. THIS OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18164078 ↗MalfunctionJan 14, 2020Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE STERILE PACKAGING OF THE EXTENSION SET WAS PEELING APART. IT WAS FURTHER REPORTED THAT THE LOCATION IS NOT ON THE PART THAT IS NORMALLY PEELED TO OPEN. THIS WAS NOTED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 9587652 ↗MalfunctionJan 14, 2020Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE STERILE PACKAGING OF SEVEN (7) EXTENSION SETS WERE PEELING APART. IT WAS FURTHER REPORTED THAT THE LOCATION IS NOT ON THE PART THAT IS NORMALLY PEELED TO OPEN. THIS WAS NOTED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 9587629 ↗MalfunctionJan 14, 2020Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE STERILE PACKAGING OF THREE (3) EXTENSION SETS WERE PEELING APART. IT WAS FURTHER REPORTED THAT THE LOCATION IS NOT ON THE PART THAT IS NORMALLY PEELED TO OPEN. THIS WAS NOTED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 9587621 ↗MalfunctionDec 26, 2019Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE RIGHT SIDE OF THE PRIMARY PACKAGING OF FOUR (4) EXTENSION SETS WAS PEELING APART. THIS WAS NOTED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 9522049 ↗MalfunctionFeb 1, 2019Crack; Crack
IT WAS REPORTED THAT THE CONNECTION ON AN EXTENSION SET CRACKED WHILE CONNECTING A SYRINGE OF PLATELETS. THE CONNECTION OF THE EXTENSION SET CRACKED BEFORE THE SYRINGE WAS FULLY CONNECTED. THIS EVENT OCCURRED DURING SETUP AND PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 8297352 ↗MalfunctionFeb 1, 2019Crack; Crack
IT WAS REPORTED THAT THE CONNECTION ON AN EXTENSION SET CRACKED WHILE CONNECTING A SYRINGE OF PLATELETS. THE CONNECTION OF THE EXTENSION SET CRACKED BEFORE THE SYRINGE WAS FULLY CONNECTED. THIS EVENT OCCURRED DURING SETUP AND PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 8297348 ↗MalfunctionJan 31, 2018Disconnection; Disconnection
IT WAS REPORTED THAT THE FEMALE ADAPTER ¿SLIPPED OFF¿ OF AN EXTENSION SET DURING A MAGNETIC RESONANCE IMAGING (MRI) PROCEDURE. THE SET WAS BEING USED TO INFUSE FENTANYL. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7230428 ↗
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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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