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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PFM MEDICAL CPP SA TITA JET LIGHT II PORT

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PFM MEDICAL CPP SA TITA JET LIGHT II PORT Back to Search Results
Model Number 616.368.2087-HA
Device Problem Biocompatibility (2886)
Patient Problem Skin Irritation (2076)
Event Date 06/10/2019
Event Type  Injury  
Manufacturer Narrative
Port product was not returned. From the information received, the allergic reaction may be occuring from the huber infusion set which is not provided as part of the port. Unable to determine the manufacturer of the huber infusion set.
 
Event Description
Port placed 2 weeks ago. Reacting poorly to where the huber needle goes in. Nurse stated that it is likely a nickel allergy. Patient has a huber needle inserted continuously for tpn infusion 18 hours/day, lactated ringers 2 hours/day nurse changes dressing and needle 1x / week, when needle removed skin itch dramatically subsides, increases when new huber needle set placed was asking if there is a non-nickel huber needle set.
 
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Brand NameTITA JET LIGHT II
Type of DevicePORT
Manufacturer (Section D)
PFM MEDICAL CPP SA
allée du quartz 9
la chaux-de-fonds, 2300
SZ 2300
Manufacturer (Section G)
PFM MEDICAL CPP SA
allee du quartz 9
la chaux-de-fonds, 2300
SZ 2300
Manufacturer Contact
troy taylor
1916 palomar oaks way
suite 150
carlsbad, CA 92008
7607588749
MDR Report Key8817269
MDR Text Key152025834
Report Number2032582-0001-02019
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072481
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 07/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number616.368.2087-HA
Device Catalogue Number616.368.2087-HA
Device Lot Number142277000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/23/2019 Patient Sequence Number: 1
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