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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE STANDARD; ANAESTHESIA CONDUCTION NEEDLE, SPINAL, SINGLE SHOT
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PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE STANDARD; ANAESTHESIA CONDUCTION NEEDLE, SPINAL, SINGLE SHOT Back to Search Results
Model Number 021151-29A
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code Device Embedded In Tissue or Plaque (3165)
Date of Event 02/13/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Event took place in (b)(6) and has been reported through (b)(6) distribution subsidiary pajunk medical produkte gmbh.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 or Problem Description
(b)(4).Tentative summarizing translation of initial reporter´s narrative: breakage of needle.Piece remained in patient and was removed in another surgery.
 
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Brand Name
SPROTTE STANDARD
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 Key8415333
Report Number9611612-2019-00004
Device Sequence Number11224183
Product Code BSP
UDI-Device Identifier14048223000257
UDI-Public14048223000257
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K911202
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Risk Manager
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 Date10/29/2023
Device Model Number021151-29A
Device Catalogue Number021151-29A
Device Lot Number1275
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/18/2019
Initial Report FDA Received Date03/13/2019
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 Required Intervention;
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