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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX; EPIDUARAL
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SMITHS MEDICAL ASD, INC. PORTEX; EPIDUARAL Back to Search Results
Catalog Number A3565-17
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Low Oxygen Saturation (2477)
Event Date 05/23/2021
Event Type  Injury  
Event Description
Information received a smiths medical pain management|portex epidural custom single shot trays required intervention.The report indicated the patient delivered at 2108 pm.Care transferred to writer after midnight, writer told that intrathecal catheter was to remain in situ for anesthesia's removal.Tubing not attached when writer received into care and no epidural pump or medications in room.Patient reporting headache, increased in severity and did not respond to analgesia.Anesthesia paged and assessed patient, found that intrathecal catheter did not have a filter or syringe attached.Same eventually found in room.Patient experienced temporary headache, required neurovital sign monitoring, oxygen supplementation.Reports from other nursing staff that multiple filters have come loose recently.
 
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Brand Name
PORTEX
Type of Device
EPIDUARAL
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
10 bowman dr.
keene NH 03431
MDR Report Key12110331
MDR Text Key259726868
Report Number3012307300-2021-06804
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
Report Date 07/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date09/30/2023
Device Catalogue NumberA3565-17
Device Lot Number4102093
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/17/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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