Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE 2.G; SPINAL NEEDLE, SINGLE USE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE 2.G; SPINAL NEEDLE, SINGLE USE Back to Search Results
Model Number 121251-27A
Device Problem Loss of or Failure to Bond (1068)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/07/2020
Event Type  malfunction  
Manufacturer Narrative
Event took place in (b)(6) and has been reported through (b)(6) distribution subsidiary (b)(4).Currently the data is poor and the device has not been returned/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.
 
Event Description
Irn#: (b)(4).Initial reporter¿s narrative: hub came off during withdrawal of cannula.
 
Manufacturer Narrative
Event took place in germany and has been reported through german distribution subsidiary pajunk medical produkte gmbh.Based on risk assessment and clinical assessment file is considered as closed.
 
Event Description
(b)(4).Initial reporter´s narrative: hub came off during withdrawal of cannula.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SPROTTE 2.G
Type of Device
SPINAL NEEDLE, SINGLE USE
Manufacturer (Section D)
PAJUNK GMBH MEDIZINTECHNOLOGIE
karl-hall-str. 1
tuttlinger str. 7
geisingen, 78187
GM  78187
MDR Report Key9605110
MDR Text Key220827776
Report Number9611612-2020-00002
Device Sequence Number1
Product Code BSP
UDI-Device Identifier14048223022808
UDI-Public14048223022808
Combination Product (y/n)N
PMA/PMN Number
K911202
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 02/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number121251-27A
Device Catalogue Number001151-683
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2020
Date Manufacturer Received01/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
-
-