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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED UTICA SOFT TIP FRAZIER INSTRM 10 FRENCH 20/CSE; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

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CONMED UTICA SOFT TIP FRAZIER INSTRM 10 FRENCH 20/CSE; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED Back to Search Results
Model Number 0031100
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Received one (b)(4) in original packaging.Lot number was verified.Performed a visual inspection, there is a hole in the seal where the device protruded through.Performed a functional inspection, the devices were dye leak tested which indicated that the packaging had an insufficient heat seal.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 28 complaints, regarding 55 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).This issue will continue to be monitored through the complaint system to assure patient safety.
 
Event Description
During incoming inspection, the distributor rejected this device, 0031100, for an insufficient heatseal.There was no contact with the patient as this was found during incoming inspection.This will be reported as a malfunction with potential for injury upon reoccurrence.
 
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Brand Name
SOFT TIP FRAZIER INSTRM 10 FRENCH 20/CSE
Type of Device
APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
Manufacturer (Section D)
CONMED UTICA
525 french rd
utica NY 13502
Manufacturer (Section G)
CONMED UTICA
525 french rd
utica NY 13502
Manufacturer Contact
samantha dewberry
525 french road
utica, NY 13502
3152230184
MDR Report Key15925250
MDR Text Key307169469
Report Number1320894-2022-00238
Device Sequence Number1
Product Code GCX
UDI-Device Identifier10653405000082
UDI-Public(01)10653405000082(17)260606(10)202106071
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 12/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number0031100
Device Catalogue Number0031100
Device Lot Number202106071
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/21/2022
Initial Date Manufacturer Received 11/30/2022
Initial Date FDA Received12/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/07/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient EthnicityNon Hispanic
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