PORTEX LATEX-FREE HYPERINFLATION SYSTEMS 008330DM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-05-29 for PORTEX LATEX-FREE HYPERINFLATION SYSTEMS 008330DM manufactured by Smiths Medical International Ltd.,.

Event Text Entries

[5917339] A report was received stating that the bag disintegrated during use. The bag would not inflate due to breakage at the neck of the device. There was no adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5


[13342923] Device evaluation: smiths medical has received the sample device. A full evaluation is anticipated, but not yet began as the device is currently in transit to the investigation site. Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.
Patient Sequence No: 1, Text Type: N, H10


[13513107] Device evaluation: one used sample was returned for evaluation. Visual inspection confirmed the tear in the bag. The bag also appeared to have scratches present in some areas. A 100% visual inspection is performed during the assembly practice. The condition of the returned sample would have been easily detected during the inspection process. Unable to determine root cause.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2183502-2015-00384
MDR Report Key4815023
Report Source06
Date Received2015-05-29
Date of Report2015-05-27
Report Date2015-05-27
Date Reported to FDA2015-05-27
Date Mfgr Received2015-05-08
Device Manufacturer Date2014-10-20
Date Added to Maude2015-06-25
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 ContactMICHELE SELIGA
Manufacturer Street1265 GREY FOX RD.
Manufacturer CityST. PAUL MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone6516287604
Manufacturer G1SMITHS MEDICAL INTERNATIONAL LTD.,
Manufacturer StreetBOUNDRY ROAD
Manufacturer CityHYTHE,KENT CT216JL
Manufacturer CountryUK
Manufacturer Postal CodeCT21 6JL
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePORTEX LATEX-FREE HYPERINFLATION SYSTEMS
Generic NameNHK-HYPERINFLATION BAG SYSTEM
Product CodeNHK
Date Received2015-05-29
Returned To Mfg2015-05-22
Model NumberNA
Catalog Number008330DM
Lot Number2806444
ID NumberNA
Device Expiration Date2017-10-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age7 MO
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL INTERNATIONAL LTD.,
Manufacturer AddressHYTHE,KENT


Patients

Patient NumberTreatmentOutcomeDate
10 2015-05-29

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