SPROTTE® 321151-31ARecalls & reported problems
Pajunk GmbH Medizintechnologie · Distal Tip: SPROTTE® Proximal End: ISO 80369-7 · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048223108611), received between Jan 5, 2022 and Sep 22, 2025 — classified as 1 injury, 1 malfunction.
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
- Detachment of Device or Device Component1
- Fracture1
Patient problems
- Foreign Body In Patient2
- 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.
InjurySep 22, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IRN# (B)(4) INCIDENT OCCURED IN SWITZERLAND. ON (B)(6) 2025: SPROTTE LUMBAR IS BROKEN OFF ON (B)(6) 2025: UPDATE OF EVENT PROBLEM: PERFORMING A LUMBAR PUNCTURE ON A PATIENT WITH DEMENTIA (A.E. LEWY BODY).INDICATION: DETERMINATION OF DEMENTIA MARKERS. PATIENT IN LEFT LATERAL POSITION, AFTER MARKING THE PUNCTURE SITE AT THE LEVEL OF THE UPPER EDGE OF THE OS ILII, DISINFECTION AND STERILE DRAPING. THE ASSISTANT DOCTOR THEN INSERTS THE SPACER NEEDLE BETWEEN THE SPINOUS PROCESSES. AFTER A SLIGHT READJUSTMENT DUE TO RESISTANCE, THE NEEDLE CAN BE INSERTED AS FAR AS IT WILL GO. THREE UNSUCCESSFUL ATTEMPTS ARE MADE TO PUNCTURE WITH THE PUNCTURE NEEDLE THROUGH THE SPACER, WITH THE USUAL READJUSTMENT AFTER EACH ATTEMPT (THE SPACER REMAINS IN SITU THROUGHOUT). THEN THERE IS A CHANGE OF HANDS; THE PUNCTURE NEEDLE IS COMPLETELY WITHDRAWN FOR THIS PURPOSE, WHILE THE SPACER REMAINS IN SITU. WHEN REINSERTING THE NEEDLE THROUGH THE SPACER, THERE IS RESISTANCE; THE NEEDLE SEEMS TO RUB SLIGHTLY AGAINST THE SPACER. WITH A LITTLE MORE PRESSURE FROM THE PUNCTURE HAND, HOLDING THE BACK OF THE NEEDLE, THE RESISTANCE CAN BE OVERCOME AND 2-3 FURTHER UNSUCCESSFUL PUNCTURE ATTEMPTS ARE MADE. A DECISION IS THEN
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 23109510 ↗MalfunctionJan 5, 2022Break; Fracture; Break; Fracture
(B)(4). EVENT TOOK PLACE IN (B)(6). CANNULA BROKEN DURING USE. PART OF 5CM REMAINED IN PT. BODY. REMOVED UNDER SURGICAL INTERVENTION THE NEXT DAY.
Patient problems: Foreign Body In Patient
MAUDE report 13166895 ↗
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- 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
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.