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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE TUOHY; NEEDLE, ANAESTHESIA CONDUCTION, SINGLE SHOT
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PAJUNK GMBH MEDIZINTECHNOLOGIE TUOHY; NEEDLE, ANAESTHESIA CONDUCTION, SINGLE SHOT Back to Search Results
Model Number 1150-7M103
Device Problems Loss of or Failure to Bond (1068); Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/14/2019
Event Type  malfunction  
Manufacturer Narrative
Needle has been supplied bulk non sterile to a kit packager.Currently the data is poor and the device has not been sent back/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.
 
Event Description
(b)(4).Initial reporter´s narrative: tonight while slowly pulling the tuohy needle out it broke.Palstic part came right off in my hand.I wasn't pulling that hard.
 
Event Description
Irn# (b)(4).Initial reporter´s narrative: tonight while slowly pulling the tuohy needle out it broke.Plastic part came right off in my hand.I wasn't pulling that hard.
 
Manufacturer Narrative
Needle has been supplied bulk non sterile to a kit packager.Currently the data is poor and the device has not been sent back/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.Based on risk assessment and clinical assessment file is considered as closed.
 
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Brand Name
TUOHY
Type of Device
NEEDLE, ANAESTHESIA CONDUCTION, SINGLE SHOT
Manufacturer (Section D)
PAJUNK GMBH MEDIZINTECHNOLOGIE
karl-hall-str. 1
tuttlinger str. 7
geisingen, 78187
GM  78187
MDR Report Key9143773
MDR Text Key166660718
Report Number9611612-2019-00026
Device Sequence Number1
Product Code BSP
Combination Product (y/n)N
PMA/PMN Number
K040965
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 12/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1150-7M103
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received09/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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