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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL EPIFUSE; ANESTHESIA CONDUCTION KIT
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NULL EPIFUSE; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number NSE4100CJP
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2021
Event Type  malfunction  
Manufacturer Narrative
A sample was received to perform an investigation.A visual inspection confirmed the reported problem.The hinge was found broken and the connector was damaged.The kit manufacturing process had a 100% inspection performed on the appearance of connectors before setting.The root cause is likely due to the molding design of the product.A device history record (dhr) review was performed and found no discrepancies or anomalies.No product information has been provided to date.(b)(4).
 
Event Description
It was reported that upon use of the product, the customer noticed the connector was damaged.No patient injury was reported.
 
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Brand Name
EPIFUSE
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section G)
NULL
MDR Report Key15322873
MDR Text Key305424891
Report Number3012307300-2022-16852
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberNSE4100CJP
Device Lot Number200626
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2021
Was the Report Sent to FDA? No
Date Manufacturer Received05/24/2022
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
Patient Sequence Number1
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