CANNULA, COHEN 8378.00M 8378.00

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-12-04 for CANNULA, COHEN 8378.00M 8378.00 manufactured by Richard Wolf Medical Instruments Corp (rwmic).

Event Text Entries

[32748289] Actual device was returned for investigation on 10/30/2015. Facility indicated package was opened and end of device fell off. Device never used on patient. Rwmic received device, with tip off, and upon visual inspection found a small amount of solder. Amount of solder was insufficient in order to maintain an intact device during normal use. Manufacturing records revealed one individual performed the soldering step for this device lot. Manufacturing instructions to be reviewed with individual to assure manufacturing steps are clearly understood. Remaining inventory to be visually inspected as well as stress tested to verify sufficient amount of solder used on any remaining devices. Two similar issues have occured (mdr1418479-2015-00041 and mdr1418479-2015-00042). Rwmic considers this report closed.
Patient Sequence No: 1, Text Type: N, H10


[32748290] Facility reported to richard wolf medical instrumentation corporation (rwmic) an attachment was placed on end of device then the tip of device fell off, out of box failure. Device in question was never used on a patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1418479-2015-00043
MDR Report Key5268226
Report SourceUSER FACILITY
Date Received2015-12-04
Date of Report2015-10-27
Date of Event2015-10-27
Date Mfgr Received2015-11-05
Device Manufacturer Date2015-05-01
Date Added to Maude2015-12-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationSERVICE PERSONNEL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS DAWN CLARK
Manufacturer Street353 CORPORTATE WOODS PARKWAY
Manufacturer CityVERNON HILLS IL 600613110
Manufacturer CountryUS
Manufacturer Postal600613110
Manufacturer Phone8003239653
Manufacturer G1RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC)
Manufacturer Street353 CORPORTATE WOODS PARKWAY
Manufacturer CityVERNON HILLS IL 600613110
Manufacturer CountryUS
Manufacturer Postal Code600613110
Single Use3
Remedial ActionIN
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCANNULA, COHEN
Generic NameCANNULA
Product CodeHHI
Date Received2015-12-04
Returned To Mfg2015-10-30
Model Number8378.00M
Catalog Number8378.00
Lot Number51003943
OperatorSERVICE PERSONNEL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerRICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC)
Manufacturer Address353 CORPORTATE WOODS PARKWAY VERNON HILLS IL 600613110 US 600613110


Patients

Patient NumberTreatmentOutcomeDate
10 2015-12-04

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