SINGLE USE PAPER FILTER WITH INDICATOR JK095

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 2019-01-30 for SINGLE USE PAPER FILTER WITH INDICATOR JK095 manufactured by Aesculap Ag.

Event Text Entries

[134592531] (b)(4). Investigation on-going. Additional information / investigation results will be provided in a supplemental report. Manufacturing site evaluation: this is a preliminary report. Only photos are available for the investigation from quality management and the products were sent to the manufacturer for an analysis. Investigation - there were visible holes in the filter. Batch history review - the device quality and manufacturing history records have been checked for the lot number and found to be according to the specifications valid at the time of production. No similar incidents have been filed with products from this batch. Conclusion and root cause - only photos are available and it is hardly possible to determine an exact conclusion and root cause. We assume that the cause of the failure is not product related. There is the possibility that the root cause of the problem is most probably usage related. Rationale - this report will be updated when we receive a statement from the manufacturer. According to the quality standard and dhr files a material defect and production error can be excluded. Due to a similar error pattern in other complaints, there is the possibility that the holes were created mechanically by an object or by faulty handling.
Patient Sequence No: 1, Text Type: N, H10


[134592532] It was reported that there was an issue with a couple single use paper filters. It was noticed that the filter paper in an instrument container had small holes, and the set was rejected due to concern about sterility. When reviewing the rest of the batch, it was possible to verify that there were more filters with the same defect which were not used. It was noted that the malfunction with the set was found prior to a procedure in the safety clinic and the scheduled surgery was postponed. On 21jan2019 additional clarification was received. It was confirmed that the procedure had not yet started, the patient was not under anesthesia, and there was no surgical delay. This report refers to the second filter which was confirmed upon product return (07jan2019). 9610612-2019-00023; 9610612-2019-00048 (this report).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2019-00048
MDR Report Key8290695
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-01-30
Date of Report2019-01-31
Date of Event2018-11-23
Date Facility Aware2019-01-09
Date Mfgr Received2019-01-31
Device Manufacturer Date2018-03-05
Date Added to Maude2019-01-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
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 NameSINGLE USE PAPER FILTER WITH INDICATOR
Generic NameSTERILE TECHNOLOGY
Product CodeFRG
Date Received2019-01-30
Returned To Mfg2019-01-07
Model NumberJK095
Catalog NumberJK095
Lot Number4509477053
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age9 MO
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP AG
Manufacturer AddressPO BOX 40 TUTTLINGEN, 78501 GM 78501


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-30

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