SPROTTE 2.GRecalls & reported problems across all models
Pajunk GmbH Medizintechnologie · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 5 models of SPROTTE 2.G by Pajunk GmbH Medizintechnologie in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Oct 27, 2016 and Sep 9, 2020 — classified as 2 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Break” (11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported SPROTTE 2.G problems
Device problems
- Break11
- Fracture9
- Fluid/Blood Leak4
- Crack3
- Loss of or Failure to Bond3
- Detachment of Device or Device Component2
- Manufacturing, Packaging or Shipping Problem2
- Product Quality Problem2
Patient problems
- No Known Impact Or Consequence To Patient10
- No Consequences Or Impact To Patient8
- No Information5
- Inadequate Pain Relief3
- Pain2
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
SPROTTE 2.G models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SPROTTE® 2.G 121251-30ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)7 reports
- SPROTTE® 2.G 121251-27ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)5 reports
- SPROTTE® 2.G 021251-29ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)5 reports
- SPROTTE® 2.G 141251-27ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)3 reports
- SPROTTE® 2.G 041251-29ANEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 report
Recent SPROTTE 2.G adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2020Break; Break
IRN #(B)(4). SUMMARIZING TENTATIVE TRANSLATION OF INITIAL REPORTER´S NARRATIVE (MALAYSIA): DEFECT BREAK THE NEEDLE AFTER MEDICATION INJECTION UPON. REMOVAL FROM PATIENT. FORTUNATELY ABLE TO REMOVE NEEDLE WITH INTRODUCER IN SITU. [NEEDLE BROKE DURING USE. PART REMAINED IN PATIENT. PART WAS REMOVED.]
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10506056 ↗MalfunctionAug 6, 2020Break; Break
IRN#: (B)(4). CANNULA IN PATIENT BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10374686 ↗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 ↗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 ↗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 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 ↗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 ↗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 ↗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 ↗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 ↗
Other Pajunk GmbH Medizintechnologie products
All Pajunk GmbH Medizintechnologie devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page