AP431-01 INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER,BACK CHECK VALVE, 12000-000-0027Recalls & reported problems
Eitan Medical Ltd · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 17290109150519), received between Oct 23, 2016 and Sep 24, 2017 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (10 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.
Most reported problems
Device problems
- Fluid/Blood Leak10
Patient problems
- No Consequences Or Impact To Patient7
- No Known Impact Or Consequence To Patient2
- No Information1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2017Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: ADMINISTRATION SET LEAKAGE OF NIVOLUMAB.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6889296 ↗MalfunctionAug 30, 2017Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: ADMINISTRATION SET LEAKAGE OF UNKNOWN DRUG.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6829498 ↗MalfunctionJun 19, 2017Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: ADMINISTRATION SET LEAKAGE OF CHEMOTHERAPY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6649490 ↗MalfunctionJan 31, 2017Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: "LEAKING AT THE TUBING WHEN THE CASSETTE WAS BEING INSERTED."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6289437 ↗MalfunctionJan 4, 2017Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: "AT THE PATIENT END OF THE SET FLUID WOULD BE SEEN TO LEAK OUT. PATIENT INVOLVEMENT: NO. DEATH/SERIOUS INJURY: NO. HUMAN HARM: NO".
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6221460 ↗MalfunctionJan 4, 2017Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: "ONE OF THE CLAMP ON THE ADMINISTRATION SET PUNCTURED THE TUBING AND FLUID LEAKED OUT FROM THE TUBING. PATIENT INVOLVEMENT: YES. HUMAN HARM: NO. DEATH/SERIOUS INJURY: DELAY IN THERAPY: YES. NEED FOR MEDICAL INTERVENTION: NO."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6221185 ↗MalfunctionDec 15, 2016Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT WAS REPORTED BY A CUSTOMER FROM (B)(6): "REPORTED LEAKING AT DISTAL TIP WHERE SPIROS CONNECTS TO CLAVE AND CLAVE CONNECTOR CONNECTS TO PICC. PATIENT INVOLVEMENT: YES; DEATH/SERIOUS INJURY: NO; HUMAN HARM: NO; DELAY IN THERAPY: YES; MEDICAL INTERVENTION NEEDED: NO".
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6176747 ↗MalfunctionDec 11, 2016Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: ADMINISTRATION SET LEAKAGE OF CHEMOTHERAPY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6165412 ↗MalfunctionNov 10, 2016Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: "LEAKING TUBING SET - TUBING LEAKING FROM THE BOTTOM OF CHAMBER. TYPE OF DRUG: UNKNOWN."
Patient problems: No Information
MAUDE report 6092059 ↗MalfunctionOct 23, 2016Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: "IV SETTING LEAKING ABOVE UPPER BACK CHECK VALVE".
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6049576 ↗
Other Set, Administration, Intravascular devices
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- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 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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