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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP INC. STERILCONTAINER S STER LOCKS PINK STERILE TECHNOLOGY

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AESCULAP INC. STERILCONTAINER S STER LOCKS PINK STERILE TECHNOLOGY Back to Search Results
Model Number US910
Device Problem Material Discolored (1170)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/29/2019
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 the locks; they were not changing color correctly after sterilization of the container. Prior to surgery, when a patient was not yet in the operating room, the malfunction was noted. The procedure was delayed for about an hour. There was no patient harm. The central sterile processing (csp) staff pulled all other applicable instrument trays and checked for color of the indicators. New locks, stored in a black back in csp, had white dots instead of pink and were not used. Additional information was not provided.
 
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Brand NameSTERILCONTAINER S STER LOCKS PINK
Type of DeviceSTERILE TECHNOLOGY
Manufacturer (Section D)
AESCULAP INC.
615 lambert pointe drive
hazelwood MO 63042
Manufacturer (Section G)
AESCULAP INC
3773 corporate parkway
center valley, pa MO 63042
Manufacturer Contact
lindsay chromiak
3773 corporate parkway
center valley, pa, MO 63042
3145515988
MDR Report Key8562637
MDR Text Key144967199
Report Number2916714-2019-00015
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093493
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUS910
Device Catalogue NumberUS910
Device Lot Number1806023
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date04/01/2019
Event Location No Information
Date Manufacturer Received06/08/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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