SPROTTE® 021151-29A (UDI 04048223103838)Recalls & reported problems
Pajunk GmbH Medizintechnologie · Distal Tip: SPROTTE® Proximal End: ISO 80369-7 · 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 04048223103838), received between Jun 21, 2021 and Jun 21, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 21, 2021Break; Break
IRN# (B)(4). TENTATIVE SUMMARIZING TRANSLATION FROM INITIAL REPORTER¿S NARRATIVE: "WOMAN PLANNED FOR ELECTIVE CESAREAN SECTION. BMI 38 (AT THE BEGINNING OF PREGNANCY), 150CM LONG, SHARPLY SWAYING BACK. SPINAL ANESTHESIA IN A SITTING POSITION WITH AN ANGLED OPERATING TABLE TO OPTIMIZE THAT THE PATIENT BENDS HIS BACK. DIFFICULT TO PALPATE VERTEBRAE DUE TO OBESITY AND DUMB, STRONG SKIN. INTRODUCER IS INTRODUCED WITHOUT REMARK. INTRODUCTION OF SPINAL SPROTTE PENCIL POINT 25G, 90MM TAKES PLACE AGAINST SLIGHTLY ELEVATED BUT CONSTANT RESISTANCE, GETS A "LOOSE" AND REMOVES THE MANDREL TO SEE IF LIQUOR EXCHANGE, WHICH DOES NOT HAPPEN. INSERT THE MANDREL AGAIN AND INSERT THE SPINAL NEEDLE FURTHER, THE SAME RESISTANCE AND NOW BOTTOMS WITH THE NEEDLE IN ITS FULL LENGTH BUT FEEL AS A CONTACT IN DEPTH AS IN BONE CONTACT. REMOVES MANDRANG AGAIN AND LOOKS FOR LIQUORS, NO BACKFLOW. THE NEEDLE GENTLY REVERSES WHILE CHECKING FOR LIQUIDS. THE SAME TOUGH, CONSTANT RESISTANCE AS WITH THE INSERTION AND WHEN BACKED 0.5-1 CM, THE RESISTANCE SUDDENLY RELEASES AND THE SPINAL NEEDLE BRAKES INSIDE THE PATIENT'S BACK. HAS CONTACT WITH THE REMAINING NEEDLE PIECES IN THE INTRODUCER, UNCLEAR WHETHER IN THE LUMEN O
Patient problems: Insufficient Information
MAUDE report 12030754 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.