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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG REUSABLE FILTER FOR CONTAINER; STERILE TECHNOLOGY
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AESCULAP AG REUSABLE FILTER FOR CONTAINER; STERILE TECHNOLOGY Back to Search Results
Model Number JK090
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/15/2020
Event Type  malfunction  
Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
 
Event Description
It was reported that there was an issue with jk090, reusable filter for container.According to the complaint description, the filter were damaged/torn.Mainly, holes or cracks in the central circle are observed.It is difficult to say for sure how many passes these filters have undergone.The average estimate would be 190 passes with a minimum of 12 cycles and a maximum of 600.There was no described patient harm.Additional information was not provided nor available.The malfunction is filed under aag reference: (b)(4).Associated medwatch-reports: 9610612-2020-00892 - (b)(4)- jk090; 9610612-2020-00893 - (b)(4)- jk090; 9610612-2020-00894 - (b)(4) - jk090; 9610612-2020-00895 - (b)(4)- jk090; 9610612-2020-00896 - (b)(4)- jk090; 9610612-2020-00897 - (b)(4)- jk090; 9610612-2020-00898 - (b)(4)- jk090; 9610612-2020-00900 - (b)(4)- jk090; 9610612-2020-00901 - (b)(4)- jk090; 9610612-2020-00902 - (b)(4)- jk090; 9610612-2020-00903 - (b)(4)- jk090; 9610612-2020-00904 - (b)(4)- jk090; 9610612-2020-00905 - (b)(4) - jk090.
 
Manufacturer Narrative
Investigation results: visual investigation: 4 filters have been received.3 filters are torn, 1 filter does not show any signs of tear.The torn area is from the center hole out in direction of the outer edge of the filter.In addition to that, the filter show a discoloration (red/orange) on the surface.The regular condition would be without any tears or damages.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that there are no similar complaints against the same lot number(s) with this error pattern.The review of risk assessment revealed that the overall risk level (severity 2 (5) probability of occurrence 1(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material, manufacturing- or design-related failure.Based upon the investigations results there is capa is not necessary.Associated medwatches: 9610612-2020-00892 - 400494548 - jk090, 9610612-2020-00893 - 400494549 - jk090, 9610612-2020-00894 - 400494550 - jk090, 9610612-2020-00895 - 400494551 - jk090, 9610612-2020-00896 - 400494552 - jk090, 9610612-2020-00897 - 400494553 - jk090, 9610612-2020-00898 - 400494554 - jk090, 9610612-2020-00899 - 400494555 - jk090, 9610612-2020-00900 - 400494556 - jk090, 9610612-2020-00901 - 400494557 - jk090, 9610612-2020-00902 - 400494558 - jk090, 9610612-2020-00903 - 400494559 - jk090, 9610612-2020-00904 - 400494560 - jk090, 9610612-2020-00905 - 400494546 - jk090.
 
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Brand Name
REUSABLE FILTER FOR CONTAINER
Type of Device
STERILE TECHNOLOGY
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM  78501
MDR Report Key11015032
MDR Text Key221833344
Report Number9610612-2020-00899
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
PMA/PMN Number
K792558
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberJK090
Device Catalogue NumberJK090
Device Lot Number4510357689
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2020
Date Manufacturer Received01/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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