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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP INC ROUND FILTERS W/INDICATOR STERILE TECHNOLOGY

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AESCULAP INC ROUND FILTERS W/INDICATOR STERILE TECHNOLOGY Back to Search Results
Model Number US751
Device Problem Material Puncture/Hole (1504)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/11/2019
Event Type  malfunction  
Manufacturer Narrative
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report. Investigation on-going.
 
Event Description
It was reported that there was an issue with the round filters. While preparing instrument packages prior to surgery, pin-size holes were found in the filters, which are sterility indicators. There was no patient harm or intervention required; however, a delay of up to 30 minutes was noted. Additional information was not available.
 
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Brand NameROUND FILTERS W/INDICATOR
Type of DeviceSTERILE TECHNOLOGY
Manufacturer (Section D)
AESCULAP INC
3773 corporate parkway
center valley, pa NY 14543
Manufacturer (Section G)
AESCULAP INC
3773 corporate parkway
center valley, pa NY 14543
Manufacturer Contact
lindsay chromiak
3773 corporate parkway
center valley, pa, PA 18034
MDR Report Key8588741
MDR Text Key144966739
Report Number2916714-2019-00010
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K944864
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 06/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUS751
Device Catalogue NumberUS751
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date03/11/2019
Event Location No Information
Date Manufacturer Received03/12/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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