SPROTTE® 2.G 121251-30ARecalls & reported problems
Pajunk GmbH Medizintechnologie · SPROTTE® 2.G Standard Sprotte Needle 2nd generation 24G x 3 1/2" (90mm), · Class 2
All models of SPROTTE 2.G (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 14048223024376), received between May 15, 2018 and Apr 11, 2019 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Fracture” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Fracture5
- Break3
- Detachment of Device or Device Component2
- Loss of or Failure to Bond2
- Detachment Of Device Component1
- Entrapment of Device1
Patient problems
- No Known Impact Or Consequence To Patient5
- No Information3
- No Consequences Or Impact To Patient2
- Device Embedded In Tissue or Plaque1
- Pain1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 11, 2019Loss of or Failure to Bond; Detachment of Device or Device Component; Loss of or Failure to Bond; Detachment of Device or Device Component
IRN#: (B)(4). INITIAL REPORTER´S NARRATIVE: HUB OF THE INTRODUCER CAME OFF UPON REMOVAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8502927 ↗MalfunctionNov 7, 2018Loss of or Failure to Bond; Fracture; Loss of or Failure to Bond; Fracture
IRN# (B)(4). SUMMARIZING TRANSLATION OF INITIAL REPORTER´S NARRATIVE: CANNULA GOT LOOSENED FROM HUB.
Patient problems: No Known Impact Or Consequence To Patient; Pain
MAUDE report 8045400 ↗MalfunctionJul 3, 2018Fracture; Fracture
(B)(4). SUMMARIZING STANDARDIZED TRANSLATION FROM INITIAL REPORTER´S NARRATIVE: THE CANULA BROKE FROM THE NEEDLE HUB
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7657713 ↗MalfunctionJun 5, 2018Break; Fracture; Break; Fracture
(B)(4). SUMMARIZING STANDARDIZED TRANSLATION FROM INITIAL REPORTER´S NARRATIVE: THE CANULA BROKE FROM THE NEEDLE HUB.
Patient problems: No Information; No Known Impact Or Consequence To Patient
MAUDE report 7568060 ↗MalfunctionJun 5, 2018Break; Fracture; Break; Fracture
(B)(4). SUMMARIZING STANDARDIZED TRANSLATION FROM INITIAL REPORTER´S NARRATIVE: THE CANULA BROKE FROM THE NEEDLE HUB.
Patient problems: No Information; No Known Impact Or Consequence To Patient
MAUDE report 7568059 ↗MalfunctionJun 5, 2018Break; Fracture; Break; Fracture
(B)(4). SUMMARIZING STANDARDIZED TRANSLATION FROM INITIAL REPORTER´S NARRATIVE: THE CANULA BROKE FROM THE NEEDLE HUB.
Patient problems: No Information; No Known Impact Or Consequence To Patient
MAUDE report 7568056 ↗MalfunctionMay 15, 2018Detachment of Device or Device Component; Detachment Of Device Component; Entrapment of Device; Detachment of Device or Device Component
IRN# 560_155-18. FROM INITIAL REPORTER´S NARRATIVE: WHEN USING THE PRODUCT THE INJECTION PLASTIC PART ON THE NEEDLE SUDDENTLY FALLS OF. PARTS OF THE NEEDLE WAS STILL IN THE PATIENS BACK. THE DOCTOR COULD GET THE NEEDLE WITHOUT HARMING THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient
MAUDE report 7513611 ↗
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.
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