SPROTTE® 021151-29A (UDI 04048223114681)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 04048223114681), received between Sep 4, 2024 and Jul 8, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2025Break; Break
IRN# (B)(4) INCIDENT OCCURRED IN ITALY. THE NEEDLE BROKE MORE OR LESS IN THE MIDDLE OF THE SHAFT AND ONE PART REMAINED TRAPPED IN THE BACK OF THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 22436796 ↗MalfunctionSep 4, 2024Break; Break
IRN# (B)(4). ORIGINAL TEXT / GERMAN: HERR DR. W WOLLTE EINE SPA STECHEN. DIES WAR FRUSTRAN. DIE ZIELSTRUKTUR WURDE NICHT ERREICHT. BEIM ZIEHEN DER NADEL IST DIESE GEBROCHEN UND CA. 5CM SIND IM PATIENTEN VERBLIEBEN. (DIE SECTIO ERFOLGTE IN VOLLNARKOSE OHNE PROBLEME) HERR R. W BESCHREIBT DIE PUNKTION OHNE JEDE PROBLEME ODER KNOCHENKONTAKT. WARUM DIE NADEL BEIM DURCHDRINGEN DER WEICHTEILE GEBROCHEN IST, IST VÖLLIG UNKLAR. TRANSLATED INTO ENGLISH: DR. W. WANTED TO PRICK A SPA. THIS WAS WITHOUT EFFECT . THE TARGET STRUCTURE WAS NOT REACHED. WHEN THE NEEDLE WAS PULLED OUT, IT BROKE AND APPROX. 5 CM REMAINED IN THE PATIENT. (THE SECTION WAS PERFORMED UNDER GENERAL ANAESTHESIA WITHOUT ANY PROBLEMS) MR. R. W. DESCRIBES THE PUNCTURE WITHOUT ANY PROBLEMS OR BONE CONTACT. IT IS COMPLETELY UNCLEAR WHY THE NEEDLE BROKE WHEN PENETRATING THE SOFT TISSUE.
Patient problems: Foreign Body In Patient
MAUDE report 20134832 ↗
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- ARROW IPN923597Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.