DEROYAL INSUFFLATION TUBING TUBING W/ 0.1UM FIL 28-0207NS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-10-03 for DEROYAL INSUFFLATION TUBING TUBING W/ 0.1UM FIL 28-0207NS manufactured by Deroyal Intercontinental.

Event Text Entries

[15755043] Customer states insufflation tubing will not allow co2 to flow through. Surgery was delayed while replacement tubing was located.
Patient Sequence No: 1, Text Type: D, B5


[15942657] (b)(4). Customer states insufflation tubing will not allow co2 to flow through. Surgery was delayed while replacement tubing was located. This incident occurred several times.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3004605321-2012-00016
MDR Report Key2822015
Report Source05,06
Date Received2012-10-03
Date of Report2012-10-03
Date of Event2008-11-13
Date Mfgr Received2008-11-13
Date Added to Maude2013-01-18
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 Street200 DEBUSK LANE
Manufacturer CityPOWELL TN 37849
Manufacturer CountryUS
Manufacturer Postal37849
Manufacturer Phone8002519864
Manufacturer G1DEROYAL INTERCONTINENTAL
Manufacturer StreetKM 7, AUTOPISTA JOAQUIN PISANO FREE ZONE
Manufacturer CitySANTIAGO
Manufacturer CountryDR
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDEROYAL INSUFFLATION TUBING
Generic NamePRODUCT CODE - HIF, INSUFFLATION TUBING
Product CodeNKC
Date Received2012-10-03
Model NumberTUBING W/ 0.1UM FIL
Catalog Number28-0207NS
Lot Number161221771
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEROYAL INTERCONTINENTAL
Manufacturer AddressSANTIAGO DR


Patients

Patient NumberTreatmentOutcomeDate
10 2012-10-03

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