SPROTTE® 121151-30A (UDI 14048223000653)Recalls & reported problems
Pajunk GmbH Medizintechnologie · SPROTTE® 24G x 3 1/2" (90mm), sterile, with Introducer 0,80 x 30mm · Class 2
All models of SPROTTE (32)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 14048223000653), received between Sep 27, 2017 and Feb 7, 2018 — classified as 1 injury, 2 malfunctions.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
- Device Misassembled During Manufacturing /Shipping1
- Failure To Adhere Or Bond1
- Fluid/Blood Leak1
- Fracture1
- Nonstandard Device1
Patient problems
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 7, 2018Break; Fracture; Break; Fracture
(B)(4). TENTATIVE SUMMARIZING TRANSLATION FROM INITIAL REPORTER´S NARRATIVE: THE CANNULA IS BROKEN OFF AND A 3 CM SECTION REMAINS IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 7246912 ↗MalfunctionJan 4, 2018Failure To Adhere Or Bond; Nonstandard Device; Device Misassembled During Manufacturing /Shipping; Failure To Adhere Or Bond; Nonstandard Device; Device Misassembled During Manufacturing /Shipping
(B)(4). INITIAL REPORTER'S NARRATIVE: NEEDLE SHAFT DETACHED FROM HUB ON INSERTION IN PATIENT.
Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient
MAUDE report 7163135 ↗MalfunctionSep 27, 2017Fluid/Blood Leak; Fluid/Blood Leak
(B)(4). FROM INITIAL USER´S NARRATIVE: FOUND LEAK FROM THE HUB OF THE SPINAL NEEDLE WHILE INJECTING THE MIX OF LOCAL ANAESTHETIC AND OPIOIDS. NO INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6896817 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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