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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PORTEX EPIDURAL CONTINUOUS TRAY; PAIN MANAGEMENT EPIDURAL TRAYS
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PORTEX EPIDURAL CONTINUOUS TRAY; PAIN MANAGEMENT EPIDURAL TRAYS Back to Search Results
Model Number NCE6234CJP
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2021
Event Type  malfunction  
Manufacturer Narrative
Returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed.Problem source was traced to manufacturing.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
 
Event Description
It was reported that during a pre use check, the customer advanced the plunger of the loss of resistance syringe, but no resistance was felt.He then found a scratch on the plunger and leakage was observed at that part.No patient injury.
 
Manufacturer Narrative
Other, other text: investigation completed on a smiths medical pain management|portex kits other.The complaint of scratch on the plunger and leakage was confirmed.It was confirmed that a part on the gasket of the syringe was chipped.Item number : 30-4503-003.Root cause may be due to manufacturing.Sample was sent to mkee for further investigation.
 
Event Description
Summary of device evaluation in h 10.
 
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Brand Name
PORTEX EPIDURAL CONTINUOUS TRAY
Type of Device
PAIN MANAGEMENT EPIDURAL TRAYS
MDR Report Key11751092
MDR Text Key248144674
Report Number3012307300-2021-03624
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 05/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberNCE6234CJP
Device Catalogue NumberNCE6234CJP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/01/2021
Was the Report Sent to FDA? No
Date Manufacturer Received03/30/2021
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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