CATHY-CLOSED S.CH12 45CM/78 36011182

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,08 report with the FDA on 2014-05-30 for CATHY-CLOSED S.CH12 45CM/78 36011182 manufactured by Unomedical Ltd..

Event Text Entries

[4583681] It was reported "inflation of catheter sleeve (making it difficult to manipulate the catheter due to the air pressure); moisture build-up inside the sleeve. " note: this reported issue occurred on five separate cases.
Patient Sequence No: 1, Text Type: D, B5


[12033432] Based on the available information, this event is deemed a reportable malfunction. It was further reported the "hospital is concerned with infection. " additional event information was provided via email on (b)(4) 2014 informing that they replaced the device due to the continued issues with sleeve inflation and moisture build-up. No information was provided or reported that any infections had occurred to patient(s); they further informed that they cannot determine exact number of patient(s) involved and the product was used in the surgical intensive care unit. They went on to inform that it is unknown how long the product was in use prior to the event occurring. Issues occurred on five (5) separate cases. A separate 3500a form has been completed for the other (4) cases under patient identifier(s) (b)(4). Mfr reports #: 3007966929-2014-00017, 00019, 00021 and 00023 respectively. (report 5 of 5) no additional patient/event details have been provided to date. Should additional information become available a follow-up report will be submitted. Note: the actual date of event is unknown, so the date used was the date convatec became aware.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3007966929-2014-00025
MDR Report Key3908201
Report Source01,05,06,07,08
Date Received2014-05-30
Date of Report2014-04-30
Date of Event2014-04-30
Date Mfgr Received2014-04-30
Device Manufacturer Date2011-01-01
Date Added to Maude2014-07-16
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 FDA0
Event Location0
Manufacturer ContactMATTHEW WALENCIAK, INT. ASS. DIR
Manufacturer Street211 AMERICAN AVE.
Manufacturer CityGREENSBORO NC 27409
Manufacturer CountryUS
Manufacturer Postal27409
Manufacturer Phone9083779293
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCATHY-CLOSED S.CH12 45CM/78
Generic NameCATHETER, NASAL, OXYGEN
Product CodeBZB
Date Received2014-05-30
Model Number36011182
Catalog Number36011182
Lot Number635427
Device Expiration Date2013-12-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerUNOMEDICAL LTD.
Manufacturer AddressZAVODSKAYA STREET 50 FANIPOL DZERZHINSK DISTRICT, MINSK REGION MINSKAYA VOBLASTS 222750 BO 222750


Patients

Patient NumberTreatmentOutcomeDate
10 2014-05-30

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