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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE; ANAESTHESIA CONDUCTION NEEDLE, SPINAL, SINGLE SHOT
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PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE; ANAESTHESIA CONDUCTION NEEDLE, SPINAL, SINGLE SHOT Back to Search Results
Model Number 021151-30C
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/28/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Manufacturer has been informed about report through fda mw5084952.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 or Problem Description
Irn# (b)(4).Initial reporter´s narrative: when removing the needle disconnected from the hub.Initial reporter´s medsun-no.: mw5084952.
 
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Brand Name
SPROTTE
Common Device Name
ANAESTHESIA CONDUCTION NEEDLE, SPINAL, SINGLE SHOT
Manufacturer (Section D)
PAJUNK GMBH MEDIZINTECHNOLOGIE
karl-hall-str. 1
tuttlinger str. 7
geisingen, baden-wuerttemberg 78187
GM  78187
MDR Report Key8502925
Report Number9611612-2019-00012
Device Sequence Number19211451
Product Code BSP
UDI-Device Identifier14048223000295
UDI-Public14048223000295
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
K911202
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 03/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date01/08/2023
Device Model Number021151-30C
Device Catalogue Number021151-30C
Device Lot Number1236
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/26/2019
Initial Report FDA Received Date04/11/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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