PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM 21-1500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,06 report with the FDA on 2012-11-19 for PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM 21-1500 manufactured by Smiths Medical Md.

Event Text Entries

[3042040] From clinical trial study organizer: it was reported that the device was implanted in patient for administration of clinical trial drug on (b)(6) 2010. According to report from clinical trial organizer the patient showed symptoms of infection including subfebrile temperature and swelling at infusion site on (b)(6) 2012. Patient was treated with paracetamol. The treating facility reported that tests of patient blood showed (b)(6) infection. Patient was then treated with vancomycin and ceftriaxon infusion. Device was explanted on (b)(6). Patient was discharged from hospital care on (b)(6) with no permanent adverse effects reported.
Patient Sequence No: 1, Text Type: D, B5


[10262046] Device evaluation: the device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2183502-2012-00567
MDR Report Key2850977
Report Source00,01,06
Date Received2012-11-19
Date of Report2012-11-16
Date of Event2012-10-22
Date Facility Aware2012-10-22
Report Date2012-11-16
Date Reported to FDA2012-11-16
Date Mfgr Received2012-10-24
Device Manufacturer Date2010-04-01
Date Added to Maude2012-11-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactPETE HIRTE
Manufacturer Street1265 GREY FOX RD.
Manufacturer CityST. PAUL MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone6516287384
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM
Generic NameLNY - CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
Product CodeLNY
Date Received2012-11-19
Returned To Mfg2012-11-06
Model Number21-1500
Catalog Number21-1500
Lot Number1768497
ID NumberNA
Device Expiration Date2015-04-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age3 YR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL MD
Manufacturer AddressST. PAUL MN US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2012-11-19

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