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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE; SPINAL NEEDLE, ANAESTHESIA CONDUCTION
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PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE; SPINAL NEEDLE, ANAESTHESIA CONDUCTION Back to Search Results
Model Number UNKNOWN
Device Problems Bent (1059); Break (1069); Fracture (1260); Human Factors Issue (2948); Device Handling Problem (3265)
Patient Problems Awareness during Anaesthesia (1707); Device Embedded In Tissue or Plaque (3165); No Information (3190)
Event Date 06/03/2016
Event Type  Injury  
Manufacturer Narrative
Event took place in (b)(6) and has been reported through (b)(4).Currently the device related data (item number, lot) 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).Tentative summarizing translation from initial reporter's narrative: female patient ((b)(6)) sectio, needle broke during difficult puncture (first puncture not successful and needle broke, second puncture for spinal anaesthesia successful), fragment of first needle retrieved during surgical intervention 2 days later.Packaging of needle has been disposed.
 
Manufacturer Narrative
Event took place in (b)(6) and has been reported through (b)(4) distribution subsidiary pajunk medical produkte (b)(4).Detailed device related data (item number, lot) is unavailable.Based on risk assessment and clinical evaluation file is considered as closed.
 
Event Description
(b)(4).Tentative summarizing translation from initial reporter's narrative: female patient ((b)(6)) sectio, needle broke during difficult puncture (first puncture not successful and needle broke, second puncture for spinal anaesthesia successful), fragment of first needle retrieved during surgical intervention 2 days later.Packaging of needle has been disposed.
 
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Brand Name
SPROTTE
Type of Device
SPINAL NEEDLE, ANAESTHESIA CONDUCTION
Manufacturer (Section D)
PAJUNK GMBH MEDIZINTECHNOLOGIE
karl-hall-str. 1
geisingen, baden-wuerttemberg 78187
GM  78187
Manufacturer (Section G)
PAJUNK GMBH MEDIZINTECHNOLOGIE
karl-hall-str. 1
geisingen, baden-wuerttemberg 78187
GM   78187
Manufacturer Contact
christian quass
karl-hall-str. 1
regulatory & safety affairs
geisingen, baden-wuerttemberg 78187
GM   78187
7704929158
MDR Report Key5725159
MDR Text Key47396024
Report Number9611612-2016-00084
Device Sequence Number1
Product Code BSP
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K911202
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/13/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received06/06/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age21 YR
Patient Weight125
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