SPROTTE® 2.G 021251-29ARecalls & reported problems
Pajunk GmbH Medizintechnologie · SPROTTE® 2.G Standard Sprotte Needle 2nd generation 25G x 3 1/2" (90mm), with introducer · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 14048223024307), received between Feb 7, 2018 and Aug 6, 2020 — classified as 2 injuries, 3 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.
Most reported problems
Device problems
- Break2
- Failure To Adhere Or Bond1
- Fluid/Blood Leak1
- Fracture1
- Material Separation1
Patient problems
- No Known Impact Or Consequence To Patient3
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2020Break; Break
IRN#: (B)(4). CANNULA IN PATIENT BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10374686 ↗InjuryJul 4, 2019Break; Fracture; Break; Fracture
IRN# (B)(4). INITIAL REPORTER´S NARRATIVE: THE NEEDLES BROKE WHEN THE DOCTOR WAS USING IT ON A PATIENT, THEY COULD TAKE OUT THE NEEDLE FROM THE PATIENTS BACK WITHOUT ANY HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8761728 ↗MalfunctionNov 23, 2018Fluid/Blood Leak; Fluid/Blood Leak
(B)(4). LEAKAGE AT THE HUB.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8099227 ↗InjuryOct 18, 2018Material Separation; Material Separation
(B)(4). TENTATIVE TRANSLATION, SUMMARIZING, FROM INITIAL REPORTER´S NARRATIVE: CANNULA IS BROKEN OFF AT THE TRANSPARENT HUB. CANNULA STILL PROTRUDED 2 MM OUT OF PATIENT'S BACK. THE CANNULA COULD BE PULLED OUT OF THE PATIENT WITH A STERILE CLAMP. PATIENT LAY IN LATERAL POSITION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7976641 ↗MalfunctionFeb 7, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond
(B)(4). TENTATIVE SUMMARIZING TRANSLATION FROM INITIAL REPORTERS NARRATIVE: NEEDLE SEPARATED FROM THE HUB.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7246914 ↗
Other NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) devices
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- 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.