babyLance BLPRecalls & reported problems
Clinical Innovations, LLC · Preemie (Pink/White) 0.85 mm depth, Safety Heelstick · Class 2
- 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 00814247020123), received between Nov 6, 2025 and Nov 6, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Extra Components” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Extra Components1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 2025Extra Components; Extra Components
REPORTED ISSUE: LANCETS HAD 2 BLADES IN IT INSTEAD OF ONE. YOU CAN SEE ON THE PICTURE WHERE THE BLADE IS FASTENED TO THE LITTLE WHITE TAB. THERE WAS ANOTHER BLADE SITTING ON TOP AND WHEN THE NURSE WENT TO STICK THE BABY'S HEEL, THE LOOSE BLADE FLEW OUT AND STUCK HER AND THE ATTACHED BLADE STUCK THE BABY. NURSE WAS HOLDING BABY'S FOOT TO COMPLETE A HEEL STICK. SHE HELD THE BABY'S LEFT LEG IN HER LEFT HAND. SHE HELD THE LANCET IN HER RIGHT HAND AND WHEN SHE PUSHED DOWN THE WHITE PIECE, A SHARPS PUNCTURED HER RIGHT POINTER FINGER. AT THE SAME TIME ANOTHER NEEDLE PUNCTURED THE BABY'S LEFT LEG. AFTER OPENING THE LANCET WE FOUND TWO INDIVIDUAL NEEDLES IN SIDE.
Patient problems: Laceration(s)
MAUDE report 23489819 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.