SPROTTE® 511151-29A (UDI 04048223116753)Recalls & reported problems
Pajunk GmbH Medizintechnologie · Needle · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048223116753), received between Nov 7, 2024 and Apr 23, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Disconnection” (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
- Disconnection1
- No Flow1
- Nonstandard Device1
Patient problems
- Inadequate Pain Relief1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2025Disconnection; Disconnection
IRN# (B)(4). INCIDENT OCCURRED IN SWEDEN: THE NEEDLE CAME OFF/DISCONNECTED FROM THE CANNULA HOLDER, SEE ATTACHED PICTURE. THE NEEDLE REMAINED IN THE PATIENT, BARELY 1 CM OF THE NEEDLE WAS VISIBLE AT THAT TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21887853 ↗MalfunctionNov 7, 2024Nonstandard Device; No Flow; Nonstandard Device; No Flow
IRN# (B)(4). INCIDENT OCCURRED IN FRANCE: ORIGINAL TEXT: RACHIANESTHÉSIE POUR CURE D'HÉMORROÏDES CHEZ UN PATIENT OBÈSE. UTILISATION D'UNE AIGUILLE, PONCTION FACILE MAIS PAS DE REFLUX DE LIQUIDE CÉPHALO RACHIDIEN. 3 ESSAIS SUPPLÉMENTAIRES INFRUCTUEUX, LE DERNIER ESSAI AVEC DES DOULEURS IRRADIANT LA FESSE DROITE PROBABLEMENT LIÉES AU FROTTEMENT AVEC UNE RACINE. ARRÊT DES ESSAIS DE PONCTION, TEST DE L'AIGUILLE AVEC DU SÉRUM. CONSTAT D'IMPOSSIBILITÉ D'INJECTION (ET DONC DE REFLUX DU LIQUIDE CÉPHALO-RACHIDIEN CAR SEMBLE BOUCHÉ. CONSÉQUENCES: 4 PONCTIONS DANS LA DURE MÈRE, RISQUES DE CÉPHALÉES POST DURALES, HÉMATOMES PÉRI-MÉDULLAIRE, LÉSIONS NEUROLOGIQUES ET PORTE D'ENTRÉE INFECTIEUSE. ACTIONS ENTREPRISES : ARRÊT COMPLET DES ESSAIS POUR UNE RACHIANESTHÉSIE. UNE ANESTHÉSIE GÉNÉRALE A ÉTÉ FAITE. SUIVI POST OPÉRATOIRE : RAS TRANSLATION: SPINAL ANESTHESIA FOR HEMORRHOID TREATMENT IN AN OBESE PATIENT. USE OF A NEEDLE, EASY PUNCTURE BUT NO REFLUX OF CEREBROSPINAL FLUID. 3 FURTHER UNSUCCESSFUL ATTEMPTS, THE LAST ONE WITH PAIN RADIATING TO THE RIGHT BUTTOCK, PROBABLY DUE TO FRICTION WITH A ROOT. PUNCTURE ATTEMPTS STOPPED; NEEDLE TESTED WITH SERUM. NO INJECTION POSSIBLE (AND THEREFORE NO CEREBROS
Patient problems: Inadequate Pain Relief
MAUDE report 20629281 ↗
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 IPN922605Teleflex 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 IPN923597Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- ARROW IPN922631Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- ARROW IPN922604Teleflex 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.