FINGERTIP 36011181

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2020-03-26 for FINGERTIP 36011181 manufactured by Unomedical Zavodskaya Street 50.

Event Text Entries

[186321758] Mdr 3007966929-2020-00014 / device 2 of 2. (b)(6). Based on the available information, this event is deemed to be a serious injury. To date no additional information has been received. Should additional information become available, a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[186321759] It was reported the "suction catheter pouch fill up with air even though block controller is off to the patient/intubation tube". End user reports "they can't input the catheter to the intubation tube if the pouch is fill up with air". The patient was on respirator in the intensive care unit at the user facility with closed suction system connected to intubation tube, there was air in the suction bag and suction could not be done. The patient needed airway aspiration quickly and treatment was delayed due to incorrect suction. " no photographs were received depicting the reported complaint issue. There was no initial report of harm to the patient when report was first made.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007966929-2020-00014
MDR Report Key9884726
Report SourceFOREIGN,HEALTH PROFESSIONAL,O
Date Received2020-03-26
Date of Event2019-10-18
Date Mfgr Received2020-03-04
Date Added to Maude2020-03-26
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 ContactMS. JEANETTE JOHNSON
Manufacturer Street7900 TRIAD CENTER DRIVE SUITE 400
Manufacturer CityGREENSBORO NC 27409
Manufacturer CountryUS
Manufacturer Postal27409
Manufacturer Phone3365424681
Manufacturer G1UNOMEDICAL ZAVODSKAYA STREET 50
Manufacturer StreetFE UNOMEDICAL LTD MINSK REGION
Manufacturer CityMINSKAYA VOBLASTS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFINGERTIP
Generic NameCATHETER AND TIP, SUCTION
Product CodeJOL
Date Received2020-03-26
Model Number36011181
Lot Number322223
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerUNOMEDICAL ZAVODSKAYA STREET 50
Manufacturer AddressFE UNOMEDICAL LTD MINSK REGION MINSKAYA VOBLASTS


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-26

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