BOTTOM FOR 3/4 CONTAINER HEIGHT:135MM JF949

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-07-03 for BOTTOM FOR 3/4 CONTAINER HEIGHT:135MM JF949 manufactured by Aesculap Ag.

Event Text Entries

[113168940] (b)(4). Manufacturing site evaluation: evaluation on-going
Patient Sequence No: 1, Text Type: N, H10


[113168941] Country of complaint: usa there is an increasing amount of sets being sent back to spd due to residue found inside container after sterilization. The or staff is doing a "white glove test" - where they will swipe the bottom of the container after removing the basket. After swiping the bottom of the container the or staff (in some cases) are finding a dark residue on glove. No patient injury. Delay in surgery all medwatch submissions related to this report are: 9610612-2018-00288, 9610612-2018-00289, 9610612-2018-00290, 9610612-2018-00291, 9610612-2018-00292, 9610612-2018-00296, 9610612-2018-00312.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2018-00312
MDR Report Key7660578
Report SourceCOMPANY REPRESENTATIVE
Date Received2018-07-03
Date of Report2018-08-22
Date of Event2018-06-01
Date Facility Aware2018-06-22
Date Mfgr Received2018-06-04
Date Added to Maude2018-07-03
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 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 NameBOTTOM FOR 3/4 CONTAINER HEIGHT:135MM
Generic NameCONTAINER BOTTOMS 1/1, 1/2, 3/4, EN
Product CodeFRG
Date Received2018-07-03
Model NumberJF949
Catalog NumberJF949
OperatorHEALTH PROFESSIONAL
Device Availability*
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP AG
Manufacturer AddressPO BOX 40 TUTTLINGEN, 78501 GM 78501


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-07-03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.