SPROTTE® 021151-30CRecalls & reported problems
Pajunk GmbH Medizintechnologie · SPROTTE® 22G x 3 1/2" (90mm), sterile, with Introducer · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14048223000295), received between Apr 11, 2019 and Oct 24, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
- Detachment of Device or Device Component1
- Loss of or Failure to Bond1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2019Loss of or Failure to Bond; Loss of or Failure to Bond
IRN# (B)(4). INITIAL REPORTER´S NARRATIVE: NEEDLE DETACHED FROM THE HUB DURING SPINAL INSERTION REMAINING IN PATIENT BACK REQUIRING SMALL INCISION TO REMOVE NEEDLE REMAINED INTACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9231207 ↗MalfunctionApr 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IRN# (B)(4). INITIAL REPORTER´S NARRATIVE: WHEN REMOVING THE NEEDLE DISCONNECTED FROM THE HUB. INITIAL REPORTER´S MEDSUN-NO.: MW5084952.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8502925 ↗
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 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.