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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG ECHO; 868.5120 ANESTHESIA CONDUCTION CATHETER
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PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG ECHO; 868.5120 ANESTHESIA CONDUCTION CATHETER Back to Search Results
Model Number 531185-31CU
Device Problems Break (1069); Material Separation (1562)
Patient Problem No Code Available (3191)
Event Date 01/20/2014
Event Type  Other  
Event Description
(b)(4).Catheter broke apart upon removal, required intervention to retrieve fragment from pt.
 
Manufacturer Narrative
No specific corrective action due to mitigative prevention of hazards is assigned to this report.A review of the relevant device history records and the raw material history files did neither indicate recorded quality problems nor rejections related to this incident.If any further info is becoming available, mfr immediately will inform fda.If no further info is becoming available, mfr considers this file as closed.
 
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Brand Name
SONOLONG ECHO
Type of Device
868.5120 ANESTHESIA CONDUCTION CATHETER
Manufacturer (Section D)
PAJUNK GMBH MEDIZINTECHNOLOGIE
karl-hall-strasse 1
geisingen, baden-wurttemberg 7818 7
GM  78187
Manufacturer Contact
christian h. quass, dir.
karl-hall-strasse 1
geisingen, baden-wurttemberg 78187
GM   78187
7049291586
MDR Report Key3772388
MDR Text Key16222862
Report Number9611612-2014-00002
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
K062900
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 02/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/01/2017
Device Model Number531185-31CU
Device Lot Number998
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/06/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/06/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2013
Is the Device Single Use? Yes
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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