VENTRICULAR CANNULA DANDY FF124R

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-12-31 for VENTRICULAR CANNULA DANDY FF124R manufactured by Aesculap Ag.

Event Text Entries

[131788032] (b)(4). Date of manufacture is 07/2018 (month/year) day of month is unknown. Investigation results: initial reporter indicated six devices of the same lot number exhibited the reported sharp edge at the drill hole/perforation. Six devices were returned for investigation. Three were in an open and used condition, the other three were returned unused in the original package. The three opened devices all have different manufacture dates, which indicates they are from different lots and none of them share the same manufacture date / lot number of the products returned in package (all three packaged are from same lot number). The device related to this medwatch report was visually and microscopically investigated. It was determined that this device displayed visible damage, including perforations. Latex examination gloves were used to determine if the perforation has a sharp edge; the glove was not damaged. The lot number of this device was not provided, therefore, review of device history records for this lot number could not be completed. Review of device quality and manufacturing records were checked for the reported lot number (4509784027) and were found to be according to specification valid at the time of production. No similar incidents were reported for this batch number. The damage present on this device may have resulted from improper handling, or may have been caused by another instrument. According to the instructions for use (ifu), the following must be observed: safe handling and preparation: - prior to each use, inspect the product for loose, bent, broken, cracked, worn or fractured components. - do not use the product if it is damaged or defective. Set aside the product if it is damaged. Inspection, maintenance and checks: - repeat cleaning and disinfection of products that still show impurities or contamination - check that the product functions correctly.
Patient Sequence No: 1, Text Type: N, H10


[131788033] It was reported that a surgeon has 6 ventricular cannulas that have a sharp edge at the drill hole / perforation that could lead to brain tissue injury when the cannula is retracted. There was no patient injury associated with these devices. All are reported as the same lot/batch number. All medwatch reports associated with this report include: 9610612-2018-00611 ; 9610612-2018-00622; 9610612-2018-00623 (this report); 9610612-2018-00624; 9610612-2018-00625; 9610612-2018-00626.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2018-00623
MDR Report Key8206777
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-12-31
Date of Report2018-12-31
Date of Event2018-12-06
Date Facility Aware2018-12-18
Date Mfgr Received2018-12-07
Device Manufacturer Date2018-07-01
Date Added to Maude2018-12-31
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. NICOLE BROYLES
Manufacturer Street615 LAMBERT POINTE DRIVE
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3145515988
Manufacturer G1AESCULAP AG
Manufacturer StreetPO BOX 40
Manufacturer CityTUTTLINGEN, 78501
Manufacturer CountryGM
Manufacturer Postal Code78501
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVENTRICULAR CANNULA DANDY
Generic NameCANNULA
Product CodeHCD
Date Received2018-12-31
Returned To Mfg2018-12-18
Model NumberFF124R
Catalog NumberFF124R
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age5 MO
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP AG
Manufacturer AddressPO BOX 40 TUTTLINGEN, 78501 GM 78501


Patients

Patient NumberTreatmentOutcomeDate
10 2018-12-31

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