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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX EPIDURAL MINIPACK; ANESTHESIA CONDUCTION KIT
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SMITHS MEDICAL ASD, INC. PORTEX EPIDURAL MINIPACK; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 100/391/128
Device Problem Material Fragmentation (1261)
Patient Problem Awareness during Anaesthesia (1707)
Event Date 10/19/2020
Event Type  malfunction  
Event Description
It was reported the catheter was placed on the 18th oct in position l3-l4 during labor.The insertion was easy and without apparent complications.A caesarean was then performed under general anesthesia because the analgesia through the catheter was not effective.The catheter was removed on 19-oct without any issue.After the removal it was noted that the catheter was thinned in the distal portion, without any more visible the terminal tip and the notches normally present there.It was suspected that a portion of the catheter may be remained inside the patient.A tac was performed in the lumbar region (d8-s2) that didn't showed the presence of radiopaque foreign body.No further adverse effects reported.
 
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Brand Name
PORTEX EPIDURAL MINIPACK
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
10 bowman dr.
keene NH 03431
MDR Report Key10901788
MDR Text Key218245420
Report Number3012307300-2020-11738
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
K965017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial
Report Date 11/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number100/391/128
Device Lot Number3994396
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age27 YR
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