Unistik 3 - Comfort 28G AT 1042Recalls & reported problems
Owen Mumford Limited · Sterile, single use safety lancet · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00384701042010), received between Oct 8, 2018 and Oct 8, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Retraction Problem” (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
- Retraction Problem1
Patient problems
- Anxiety1
- Discomfort1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 8, 2018Retraction Problem; Retraction Problem
OWEN MUMFORD LIMITED WAS NOTIFIED OF EVENT ON 08 SEP 2018 (B)(6). A NURSE TOOK A BLOOD SAMPLE OF A BABY IN NEONATOLOGY SERVICE WITH THE UNISTIK 3 COMFORT DEVICE. WHEN SHE WAS REMOVING HER GLOVES SHE WAS INJURED WITH THE DEVICE. SHE HAS A MARK ON THE THUMB WITH EXTENSIVE BLEEDING, AS THE NEEDLE DID NOT RETRACT ENTIRELY INTO THE BODY OF THE DEVICE. SHE HAS NOT RECEIVED ANY FOLLOW-UP AND TREATMENT IN TERMS OF SEROLOGY POST NSI, AS THE PATIENT WAS NEGATIVE.
Patient problems: Anxiety; Discomfort; Patient Problem/Medical Problem
MAUDE report 7945160 ↗
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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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