Standard Sprotte Needle 321151-31A (UDI 14048223002428)Recalls & reported problems
Pajunk GmbH Medizintechnologie · Standard Sprotte Needle 21G x 3 1/2" (90mm), sterile, with Introducer and wings · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 14048223002428), received between Jan 4, 2018 and Feb 19, 2020 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Failure To Adhere Or Bond” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Failure To Adhere Or Bond2
- Fracture2
- Loss of or Failure to Bond1
Patient problems
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 19, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
(B)(4). SUMMARIZING TENTATIVE TRANSLATION OF INITIAL REPORTERS NARRATIVE: NEEDLE CAME OFF THE HUB AND HAD TO BE REMOVED USIG SURGICAL CLAMP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9724718 ↗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 8045398 ↗MalfunctionJan 19, 2018Failure To Adhere Or Bond; Fracture; Failure To Adhere Or Bond; Fracture
(B)(4). INITIAL REPORTER´S NARRATIVE: DAMAGE OF THE CANNULA. DAMAGE OF RETAINING PLATE/ WINGS.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7204918 ↗MalfunctionJan 4, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond
(B)(4). SUMMARIZING TRANSLATION FROM INITIAL REPORTERS NARRATIVE: RETAINING PLATE/ WINGS OF SPINAL NEEDLE CAME OFF DURING INTERVENTION (BREAKAGE?).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7163133 ↗
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
- 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 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
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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