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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE INFILTRALONG; PERIPHERAL NERVE BLOCK INFILTRATION CATHETER

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PAJUNK GMBH MEDIZINTECHNOLOGIE INFILTRALONG; PERIPHERAL NERVE BLOCK INFILTRATION CATHETER Back to Search Results
Model Number 021159-20B
Device Problems Break (1069); Fracture (1260); Patient-Device Incompatibility (2682); Device-Device Incompatibility (2919); Mechanical Jam (2983); Device Handling Problem (3265)
Patient Problems Awareness during Anaesthesia (1707); Foreign Body In Patient (2687)
Event Date 07/11/2016
Event Type  malfunction  
Manufacturer Narrative
Event took place in (b)(6) and has been reported through (b)(6).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
Internal report-number: (b)(4).Tentative summarizing translation of initial reporter's narrative: catheter breakage.
 
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: catheter breakage.
 
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Brand Name
INFILTRALONG
Type of Device
PERIPHERAL NERVE BLOCK INFILTRATION CATHETER
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 Key5804549
MDR Text Key50729092
Report Number9611612-2016-00100
Device Sequence Number1
Product Code BSO
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K080675
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Expiration Date01/01/2021
Device Model Number021159-20B
Device Catalogue Number021159-20B
Device Lot Number1147
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/25/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received07/11/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2016
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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