CAPIOX BUBBLE TRAPS XX*XH041

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 2010-06-10 for CAPIOX BUBBLE TRAPS XX*XH041 manufactured by Terumo Corporation, Ashitaka.

Event Text Entries

[15206951] The user facility reported that during set-up, the holder for the bubble trap broke. The product was changed out and the surgery was completed successfully.
Patient Sequence No: 1, Text Type: D, B5


[15692070] The actual device was not returned to terumo for eval. A review of the dhr of the involved product code for the period of the past three years confirmed there were no indications of production related problems. A review of the complaint files confirmed that there have been no previous reports for this product code. With no lot number info, the mfg date of the actual device was untraceable. The expiration of this product code is not established due to the product nature. The cause of this event cannot be determined due to the absence of the actual device and lot number. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9681834-2010-00051
MDR Report Key2581444
Report Source05,06
Date Received2010-06-10
Date of Report2010-05-17
Date of Event2010-05-12
Date Facility Aware2010-05-17
Report Date2010-05-17
Date Mfgr Received2010-05-17
Date Added to Maude2012-05-23
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 ContactMICHAEL SILVESTRI, MANAGER
Manufacturer Street125 BLUE BALL ROAD
Manufacturer CityELKTON MD 21921
Manufacturer CountryUS
Manufacturer Postal21921
Manufacturer Phone8002623304
Manufacturer G1ASHITAKA CORPORATION, ASHITAKA
Manufacturer Street150 MAIMAIGI-CHO
Manufacturer CityFUJINOMIYA CITY, SHIZUOKA, PREF, 418
Manufacturer CountryJA
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameCAPIOX BUBBLE TRAPS
Generic NameBUBBLE TRAP
Product CodeKRL
Date Received2010-06-10
Model NumberNA
Catalog NumberXX*XH041
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTERUMO CORPORATION, ASHITAKA
Manufacturer Address150 MAIMAIGI-CHO FUJINOMIYA CITY, SHIZUOKA, PREF, 418 JA


Patients

Patient NumberTreatmentOutcomeDate
10 2010-06-10

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