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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE; LUMBAR PUNCTURE NEEDLE

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PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE; LUMBAR PUNCTURE NEEDLE Back to Search Results
Model Number 321151-31A
Device Problems Fitting Problem (2183); Device Issue (2379); Device Misassembled During Manufacturing /Shipping (2912); Incorrect Device Or Component Shipped (2962); Mechanical Jam (2983)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 05/01/2016
Event Type  malfunction  
Manufacturer Narrative
Event took place in (b)(6) and has been reported through (b)(4).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).Tentative summarizing translation of initial reporter's narrative: spinal needle does not fit with introducer.
 
Manufacturer Narrative
Based on risk assessment and clinical evaluation file is considered as closed.
 
Event Description
(b)(4).Tentative summarizing translation of initial reporter's narrative: spinal needle does not fit with introducer.
 
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Brand Name
SPROTTE
Type of Device
LUMBAR PUNCTURE NEEDLE
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 Key5688109
MDR Text Key46202947
Report Number9611612-2016-00071
Device Sequence Number1
Product Code BSP
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K911260
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 10/06/2016
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
Device Operator Physician
Device Expiration Date03/01/2021
Device Model Number321151-31A
Device Catalogue Number321151-31A
Device Lot Number1154
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/11/2016
Initial Date FDA Received05/31/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received10/06/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2016
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) Other;
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