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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® EPIDURAL MINIPACKS ANESTHESIA CONDUCTION KIT

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SMITHS MEDICAL ASD, INC. PORTEX® EPIDURAL MINIPACKS ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 100/391/118CZ
Device Problems Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Patient Problems Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Event Date 08/17/2018
Event Type  Injury  
Manufacturer Narrative
Device evaluation in progress.
 
Event Description
It was reported that the catheter in the epidural mini pack system, broke during insertion. A portion if the catheter remained in the patient's body. The broken catheter was removed by surgery, and the event was resolved. The patient's condition was reported as stable.
 
Manufacturer Narrative
One catheter was returned for analysis in a plastic bag with its original unit pack. Under visual inspection we noticed that catheter is not complete; the tip was missing. The returned sample was measured and compared to a non-used sample finding that 10. 7cm were missing. The catheter was noted to be cut by a sharp object under magnification. The manufacturing process was reviewed. The reported complaint occurred during the procedure with its most probable cause of cut by the tuohy needle when the catheter was pulled back. Ifu was reviewed finding that it states to never pull back the catheter through the epidural tuohy needle. Based on the evidence, the complaint is confirmed with the root cause being user interface as the reported failure was cause by the customer during practice which is in conflict with the instructions for use (ifu).
 
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Brand NamePORTEX® EPIDURAL MINIPACKS
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key7891755
MDR Text Key120821016
Report Number3012307300-2018-03860
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 distributor,foreign
Type of Report Initial,Followup
Report Date 11/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number100/391/118CZ
Device Lot Number3488259
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/04/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/19/2018 Patient Sequence Number: 1
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