BOTTOM FOR 3/4 CONTAINER HEIGHT:135MM JK742

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-12-20 for BOTTOM FOR 3/4 CONTAINER HEIGHT:135MM JK742 manufactured by Aesculap Ag.

Event Text Entries

[131929887] (b)(4). Manufacturing site evaluation: failure description - several scratches can be found on the surface of all container components, most likely caused by wear and tear. In addition, one container bottom and lid was discolored in brown/black. No deviation was found on the retention place and the filter. The provided particles are glued onto a sheet of paper with adhesive tape. Investigation - investigation carried out on the pictorial documentation visually and microscopically. In similar complaints, the detected brown/black discoloration was tested and had a negative result with fluoric acid on the product surface. This layer (elevated chrome content) through our results can only be removed mechanically, not by any basic cleaner or other chemical. In most cases these layers are created by a chemical reaction of the product with the product surface with phosphor-containing liquids, such as neutralizer base in phosphoric acids in machine cleaning processes. Dosage errors or insufficient rinsing may be the cause. Such discoloration does not reduce the lifetime of the product nor does it represent a hygienic risk. A material or manufacturing issue was not detected. According to the ifu, sterile container s can use hydrogen peroxide for sterilization. Certain fragments are most likely fragments of container feet. The breakage of these fragments was most likely caused by extensive force, since the analysis of the fracture pattern illustrated a forced fracture due to overload. No pores, inclusions or foreign bodies could be found on the point of rupture. Other fragments are small and black whose origin is yet unknown. In the container system there are 2 components made of black material, the feet of the basket and the mechanism of the retention plate. Nevertheless, the black fragment could also originate from a device or similar products during reprocessing. There was one grey, shiny fragment which was most probably from another device or instrument. In 2016, a similar issue with black flakes in sterile containers occurred, caused by a worn injection-molding tool. In this case, a "vendor related defect" notification was created and corrective action was taken. There was rework of the tool with an optimized design of the foot. Since 27mar2017, no more products were produced according to the old production standards. According to the ifu, new sterile containers must be cleaned prior to the first use, to wash out foreign objects. Since the basket and hence the feet were not available, we cannot determine a final root cause of this failure. No missing parts or deviations can be found on the provided retention plate. Conclusion and root cause- based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage. Rationale - the basket and feet were not available, nor the date of production. Nevertheless, there are new feet available since march 2017, thus the feet as the root cause can be excluded. If the feet are older than march 2017, the failure would have occurred earlier and could have been prevented by washing it out prior to the first use.
Patient Sequence No: 1, Text Type: N, H10


[131929888] It was reported that metal shavings and black/grey residue were found in the bottom of an instrument container. The issue was noted in the operating room but prior to use of the contents in the sterile field. There was a 10-minute delay in surgery but there was no patient harm or intervention required. The case was a urology procedure. It was felt that the repetition of placing lids on and off the bottom may be causing this malfunction. This case represents the component - bottom for 3/4 container. Associated medwatches: 9610612-2018-00584, 9610612-2018-00585, 9610612-2018-00586 (this report), 9610612-2018-00587.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2018-00586
MDR Report Key8187218
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-12-20
Date of Report2019-01-07
Date of Event2018-09-16
Date Facility Aware2018-12-11
Date Mfgr Received2018-12-11
Device Manufacturer Date2016-10-01
Date Added to Maude2018-12-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 NameBOTTOM FOR 3/4 CONTAINER HEIGHT:135MM
Generic NameSTERILIZATION CONTAINERS
Product CodeFRG
Date Received2018-12-20
Returned To Mfg2018-12-05
Model NumberJK742
Catalog NumberJK742
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age30 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 2018-12-20

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