SPROTTE® 2.G 121251-27ARecalls & reported problems
Pajunk GmbH Medizintechnologie · SPROTTE® 2.G Standard Sprotte Needle 2nd generation 27G x 3 1/2" (90mm) with Introducer · Class 2
All models of SPROTTE 2.G (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 14048223022808), received between Oct 27, 2016 and Jan 20, 2020 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Fracture3
- Crack1
- Inadequacy of Device Shape and/or Size1
- Loss of or Failure to Bond1
- Patient-Device Incompatibility1
Patient problems
- No Consequences Or Impact To Patient4
- Foreign Body In Patient1
- Inadequate Pain Relief1
- No Known Impact Or Consequence To Patient1
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 20, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
(B)(4). INITIAL REPORTER´S NARRATIVE: HUB CAME OFF DURING WITHDRAWAL OF CANNULA.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9605110 ↗MalfunctionOct 24, 2019Break; Break
(B)(4). INITIAL REPORTER´S NARRATIVE: THE PLASTIC-CONTAINER BROKE WHEN THEY INSERTED THE NEEDLE INTO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9231209 ↗MalfunctionJul 4, 2019Break; Fracture; Break; Fracture
(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 8761730 ↗MalfunctionNov 7, 2018Fracture; Fracture
IRN# (B)(4). SUMMARIZING TRANSLATION OF INITIAL REPORTER´S NARRATIVE: CANNULA GOT LOOSENED FROM HUB.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8045406 ↗MalfunctionOct 27, 2016Break; Crack; Fracture; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Break; Crack; Fracture; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility
(B)(4). SUMMARIZING TENTATIVE TRANSLATION FROM INITIAL REPORTER´S NARRATIVE: NEEDLE BROKE WITHIN PATIENT UPON SPINAL ANAESTHESIA. NEUROLOGICAL EVALUATION: LEAVE FRAGMENT WITH PATIENT. PATIENT IS QUITE VOLUMINOUS. DIFFICULT APPROACH.
Patient problems: Foreign Body In Patient; Inadequate Pain Relief; Pain
MAUDE report 6059529 ↗
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 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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