SPROTTE® 141151-27ARecalls & reported problems
Pajunk GmbH Medizintechnologie · Distal Tip: SPROTTE® Proximal End: ISO 80369-7 · Class 2
All models of SPROTTE (32)
Data updated Oct 16, 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 04048223107584), received between Nov 11, 2024 and Nov 11, 2024 — 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. 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.
MalfunctionNov 11, 2024Break; Break
IRN# (B)(4). ORIGINAL TEXT (FRANCE): LE (B)(6) 2024 MATIN, L'ANESTHÉSISTE RÉALISE UNE RACHI ANESTHÉSIE CHEZ UNE PATIENTE QUI A DÉJÀ EU UNE CHIRURGIE DU RACHIS (SANS POSE DE MATÉRIEL). LORS DE LA RÉALISATION DE LA RACHI ANESTHÉSIE SENSATION DE TISSU SOUS CUTANÉE DUR ET RIPPANT LORS DE L'AVANCÉ DE L'AIGUILLE PROBABLEMENT EN RAPPORT AVEC LA FIBROSE POST OPÉRATION. SENSATION DE DURETÉ IMPORTANTE AU BOUT DE L'AIGUILLE DE L'ANESTHÉSISTE EN RAPPORT AVEC UN CONTACT OSSEUX. RETRAIT DE L'AIGUILLE POUR RÉORIENTATION. CONSTATATION QU'IL MANQUE UNE PARTIE IMPORTANTE DE L'AIGUILLE, LE MÉDECIN EN DÉDUIT DONC QUE LE RESTE EST À L'INTÉRIEUR DE LA PATIENTE. ANNULATION DE L'OPÉRATION ET REPORT AFIN DE LA PRENDRE EN CHARGE ET RETIRER SOUS SCANNER CE CORPS ÉTRANGER. LORS DU SCANNER DIAGNOSTIQUE : BOUT DE L'AIGUILLE EN CONTACT AVEC LE PROCESSUS TRANSVERSE GAUCHE DE L5 ET L'AUTRE EXTRÉMITÉ DANS LE TISSU ADIPEUX À 4 CM SOUS LA SURFACE DE LA PEAU. SUCCÈS DE L'INTERVENTION DU RADIOLOGUE QUI A RÉALISÉ L'ABLATION DE L'AIGUILLE SOUS ANESTHÉSIE LOCALE GUIDÉE PAR SCANNER. TRANSLATION TEXT (ENGLISH): ON THE MORNING OF (B)(6) 2024, THE ANAESTHETIST PERFORMED A RACHI ANAESTHESIA ON A PATIENT WHO HAD ALREADY UNDERGO
Patient problems: Foreign Body In Patient
MAUDE report 20652216 ↗
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 16, 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