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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL PORTEX EPIDURAL CUSTOM CONTINUOUS TRAYS; ANESTHESIA CONDUCTION KIT
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NULL PORTEX EPIDURAL CUSTOM CONTINUOUS TRAYS; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number NCE6344
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2020
Event Type  malfunction  
Event Description
It was reported that the hinge part of the connector was noticed to be broken in two during use.No patient injury was reported.
 
Manufacturer Narrative
Udi information is unknown.Manufacturing site address is unknown.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.It was confirmed that the hinge part of the epifuse connector was broken and split into two.Unable to determine the root cause of the reported issue.(b)(4).
 
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Brand Name
PORTEX EPIDURAL CUSTOM CONTINUOUS TRAYS
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section G)
NULL
MDR Report Key15316322
MDR Text Key305374868
Report Number3012307300-2022-16618
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K172410
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberNCE6344
Device Lot Number200602
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2020
Was the Report Sent to FDA? No
Date Manufacturer Received04/12/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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