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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. PORTEX ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number A4134-17
Device Problems Material Protrusion/Extrusion (2979); Material Split, Cut or Torn (4008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/12/2020
Event Type  malfunction  
Event Description
Pt is an adult female s/p labor epidural placement. Pt had epidural catheter placed uneventfully for labor analgesia. Post delivery, when nurse attempted to remove the catheter, she noted that plastic cover was sheared off at 5 cm and the internal wire exposed and stretching out. Md was notified immediately to evaluate epidural catheter and the md pulled the epidural wire under slow continuous pressure and it was removed completely. Did not appear to have a wire breakage. Pt was evaluated by neuro surgery, had ct imaging which did not demonstrate any foreign body.
 
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Brand NamePORTEX
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key10493654
MDR Text Key205693161
Report Number10493654
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 07/28/2020,07/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberA4134-17
Device Catalogue NumberA4134-17
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/28/2020
Event Location No Information
Date Report to Manufacturer09/04/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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