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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG FILTER RETENTION PLATE STERILIZATION CONTAINERS

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AESCULAP AG FILTER RETENTION PLATE STERILIZATION CONTAINERS Back to Search Results
Model Number JK100
Device Problems Loose or Intermittent Connection (1371); Residue After Decontamination (2325); Device Contaminated During Manufacture or Shipping (2969); Scratched Material (3020)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/01/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Manufacturing site evaluation: po residue found after sterilization on product jk100 and md344. Jk100: the device arrived in a clean status without visible damage. During the investigation a loosened filter retention plate jk100 and round filter polypropylene md344. Additionally we found visible damages and scratches. A visual inspection of the filter retention plate. We found no visual failure. Additionally we made a functional test according to the sterile container functional test. Checking the filter holder, we found that the filter holder do not have a full surface contact at the edge. Next a visual inspection was performed of the round filter polypropylene md344. We found visible damages and a cut. Jk100: the products does not require batch management; a review of the device quality and manufacturing history records is not possible. Md344: a review of the device quality and manufacturing history records is not possible because the batch number is unknown. Conclusion: the root cause of the problem is most probably usage and design related.

 
Event Description

It was reported by the healthcare professional to the company sales representative "there is an increasing amount of sets with residue found inside container after sterilization". After swiping the bottom of the container the or staff (in some cases) are finding a dark residue on glove. No patient injury. No delay in surgery. Components in use listed as concomitant devices are: filter retention plate / jk100, round filter polypropylene / md344.

 
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Brand NameFILTER RETENTION PLATE
Type of DeviceSTERILIZATION CONTAINERS
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer (Section G)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer Contact
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
MDR Report Key7810828
MDR Text Key118262277
Report Number9610612-2018-00362
Device Sequence Number1
Product Code FLE
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK792558
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 06/04/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/23/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberJK100
Device Catalogue NumberJK100
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/24/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date07/26/2018
Event Location No Information
Date Manufacturer Received06/04/2018
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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