SPROTTE® NRFit 021163-29A (UDI 04048223127841)Recalls & reported problems
Pajunk GmbH Medizintechnologie · SPROTTE® NRFit 25G x 3 1/2" (90mm) with magnification and IntroDucer NRFit 30mm, sterile · Class 2
All models of SPROTTE NRFit (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048223127841), received between Dec 5, 2025 and Dec 5, 2025 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 5, 2025Break; Break
(B)(4). INCIDENT OCCURRED IN UK. ATTEMPTED SPINAL ANAESTHESIA FOR MAJOR ROBOTIC UROLOGY SURGERY. UPON REMOVAL OF THE NEEDLE AND THE INTRODUCER TOGETHER TO ATTEMPT A FINAL TIME WITH A LONGER 25G NEEDLE, I NOTICED THAT THE PART OF THE SPINAL NEEDLE WAS RETAINED. THE NEEDLE BROKE AT THE LEVEL OF THE INTRODUCER WITH THE TIP RETAINED IN THE SUBCUTANEOUS TISSUE. NO RESISTANCE OR DIFFICULTY IN REMOVING OR INSERTING THE NEEDLE. I JUST HIT THE BONE A FEW TIMES DURING THE ATTEMPTS. NEEDLE VISUALISED WITH US. EXPLAINED TO THE PATIENT THAT WE WOULD NEED TO SURGICALLY REMOVE THE NEEDLE. SHE UNDERSTOOD THE SITUATION AND AGREED TO PROCEED. DECIDED TO PUT HER UNDER GENERAL ANAESTHESIA TO PERFORM XRAY AND PROCEED WITH THE REMOVAL. SHE AGREED TO CONTINUE WITH PLANNED SURGERY IF REMOVAL UNCOMPLICATED. TOTAL LIDOCAINE 1% 20 MLS. SPINE SURGICAL TEAM ARRIVED. NEEDLE WAS IDENTIFIED WITH FLUOROSCOPY AND REMOVED. PATIENT WAS PRONED FOR THE PROCEDURE AND THE SURGICAL WOULD WAS OF ABOUT 1 INCH IN LENGTH. UNEVENTFUL PROCEDURE WITH NO IMMEDIATE COMPLICATION. THE NEEDLE WAS FOUND AT THE LEVEL OF L2 CLOSE TO THE SPINOUS PROCESS, FAR FROM THE SPINAL CANAL. AFTER THE NEEDLE WAS REMOVED WE PROCEED WITH THE PLANNED
Patient problems: Foreign Body In Patient
MAUDE report 23725456 ↗
Other NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) devices
- ARROW IPN922632Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)2 recalls0 reports
- ARROW IPN922603Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- ARROW IPN922604Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- 22G 1 1/2IN Regional Block Needle 408348Becton, Dickinson And Company · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- ARROW IPN922631Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- ARROW IPN923597Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- ARROW IPN922605Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- BD QUINCKE Spinal Needles 405180Becton, Dickinson And Company · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)23 reports
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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page