7 in (18 cm) Q2 T connector Extension Set w/ Q2 T-site-checkvalve, microbore tub 95701Recalls & reported problems
Quest Medical Inc · 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 00634624957015), received between Nov 8, 2017 and May 20, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Backflow” (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
- Adverse Event Without Identified Device or Use Problem1
- Backflow1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2022Backflow
A REPORT WAS RECEIVED BY QUEST MEDICAL FROM BOSTON'S CHILDREN'S HOSPITAL TO REPORT AN ISSUE WITH PRODUCT CODE 94701. IT WAS STATED THAT DURING USE, THERE WAS ALLEGED BACKFLOW OF MEDICATION THROUGH THE CHECKVALVE FOR TWO SETS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14461928 ↗MalfunctionNov 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PRODUCT DISTRIBUTOR REPORTED AN ISSUE ENCOUNTERED BY THEIR CUSTOMER WHEN USING THE FLUID DELIVERY EXTENSION SET. THE REPORT STATED THAT A PIECE OF THE DEVICE BROKE OFF DURING DELIVERY OF ANESTHESIA TO A PATIENT DURING A CATARACT PROCEDURE. THEY REPORTED THAT THE FURTHEST PORT, THE ONE AT THE 180 DEGREE ANGLE, IS THE ONE THAT COMPLETELY DISCONNECTED FROM THE REST OF THE TUBING AND THAT THE EXTENSION THAT SITS AT A 90 DEGREE ANGLE TO THE MAIN TUBING WAS INTACT. THEY REPORTED THE BREAK WAS VERY CLEAN WITH N APPARENT MISHANDLING OR SEVERE DAMAGE TO THE UNIT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE DEVICE WAS DISCARDED BY THE CUSTOMER AND NOT RETURNED FOR EVALUATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7011813 ↗
Other Tubing, Fluid Delivery devices
- High Pressure Tubing CMerit Medical Systems, Inc. · Tubing, fluid delivery1 recall0 reports
- High Pressure Tubing CMerit Medical Systems, Inc. · Tubing, fluid delivery1 recall0 reports
- Medex MX43660Icu Medical, Inc. · Tubing, fluid delivery27 reports
- Medex MX43860Icu Medical, Inc. · Tubing, fluid delivery13 reports
- Medex MX452FLIcu Medical, Inc. · Tubing, fluid delivery5 reports
- Medex MX451FLIcu Medical, Inc. · Tubing, fluid delivery5 reports
- 10 in. (25 cm) Q2 Checkmate extension set 9545Quest Medical Inc · Tubing, Fluid Delivery3 reports
- Medex MX450FLIcu Medical, Inc. · Tubing, fluid delivery3 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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