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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 121251-30A
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/11/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Based on risk management file and clinical evaluation report this file is considered as closed.
 
Event or Problem Description
(b)(4).Summarizing standardized translation from initial reporter´s narrative: the canula broke from the needle hub.
 
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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. 07
geisingen, baden-wuerttemberg 78187
GM  78187
MDR Report Key7657713
Report Number9611612-2018-00029
Device Sequence Number1652601
Product Code BSP
UDI-Device Identifier14048223024376
UDI-Public14048223024376
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K911202
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/03/2018
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 Other Health Care Professional
Device Expiration Date01/15/2023
Device Model Number121251-30A
Device Catalogue Number121251-30A
Device Lot Number1237
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2018
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/11/2018
Initial Report FDA Received Date07/03/2018
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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