AP331-01 - NON PVC UV RESISTANT MICROBORE WITH VENTED/NON-VENTED SPIKE 12007-000-0005Recalls & reported problems
Eitan Medical Ltd · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 17290109150427), received between Mar 19, 2017 and Jun 19, 2017 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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.
Most reported problems
Device problems
- Fluid/Blood Leak4
Patient problems
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
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 Consequences Or Impact To Patient
MAUDE report 6649492 ↗MalfunctionApr 24, 2017Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: LEAKAGE OF ORENCIA.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6515077 ↗MalfunctionApr 18, 2017Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: LEAKAGE OF ORENCIA.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6499496 ↗MalfunctionMar 19, 2017Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: ADMINISTRATION SET LEAKAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6416158 ↗
Other Set, Administration, Intravascular devices
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- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- 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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