SPROTTE® 021151-29A (UDI 14048223000257)Recalls & reported problems
Pajunk GmbH Medizintechnologie · SPROTTE® 25G x 3 1/2" (90mm), sterile, with Introducer 0,8 x 30mm · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 14048223000257), received between Feb 26, 2018 and Jul 23, 2020 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
- Fracture2
- Break1
- Failure To Adhere Or Bond1
Patient problems
- No Consequences Or Impact To Patient2
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 23, 2020Break; Break
IRN#: (B)(4). TENTATIVE TRANSLATION OF INITIAL REPORTER´S NARRATIVE: CANNULA BREAKAGE DURING SPINAL ANAESTHESIA.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10315599 ↗InjuryMay 24, 2019Fracture; Fracture
(B)(4). TENTATIVE TRANSLATION FROM INITIAL REPORTERS NARRATIVE: BREAKAGE OF NEEDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8639249 ↗InjuryMar 13, 2019Fracture; Fracture
(B)(4). TENTATIVE SUMMARIZING TRANSLATION OF INITIAL REPORTER´S NARRATIVE: BREAKAGE OF NEEDLE. PIECE REMAINED IN PATIENT AND WAS REMOVED IN ANOTHER SURGERY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8415333 ↗MalfunctionFeb 26, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond
IRN# (B)(4). SUMMARIZING TENTATIVE TRANSLATION OF INITIAL REPORTER´S NARRATIVE: UPON REMOVAL OF THE SPINAL NEEDLE AND THE INTRODUCER THE HUB OF THE INTRODUCER CAME OFF THE NEEDLE.
Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient
MAUDE report 7295480 ↗
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- 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.