Port Access Needle S02019-75Recalls & reported problems
Bard Access Systems, Inc. · MiniLoc 19G x 0.75 inch · Class 2
- 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 00801741048708), received between Aug 23, 2018 and Aug 23, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Component Missing” (2 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Component Missing2
Patient problems
- Needle Stick/Puncture2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 23, 2018Component Missing
THE PATIENT'S MOTHER REPORTED THAT WHEN SHE OPENED THE MINILOC TO ACCESS HER SON'S PORT THE PLASTIC NEEDLE COVERING WAS MISSING AND SHE STABBED HERSELF THROUGH HER GLOVE. SHE STATED THAT SHE HAD TO REDO THE STERILE FIELD AND OPEN ANOTHER NEEDLE WHICH WAS ALSO MISSING THE COVERING BUT SHE WAS ABLE TO PLACE IT. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: Needle Stick/Puncture
MAUDE report 7811514 ↗MalfunctionAug 23, 2018Component Missing
THE PATIENT'S MOTHER REPORTED THAT WHEN SHE OPENED THE MINILOC TO ACCESS HER SON'S PORT THE PLASTIC NEEDLE COVERING WAS MISSING AND SHE STABBED HERSELF THROUGH HER GLOVE. SHE STATED THAT SHE HAD TO REDO THE STERILE FIELD AND OPEN ANOTHER NEEDLE WHICH WAS ALSO MISSING THE COVERING BUT SHE WAS ABLE TO PLACE IT. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: Needle Stick/Puncture
MAUDE report 7811510 ↗
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.