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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 45-0299 REV. 100
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problems Numbness (2415); Device Embedded In Tissue or Plaque (3165)
Event Date 03/27/2020
Event Type  malfunction  
Event Description
A middle-aged female presented in labor. She was scheduled for repeat cesarean section today but decided for trial of labor. She had history of chari malformation type i s/p decompression. She has had two epidurals before, including one after decompression. Other than some neck pain after the first epidural, the procedures were done without incident. The anesthesiology attempted to place a l3/4 epidural. On one attempt there was loss of resistance and started to thread the catheter. The anesthesiologist felt some resistance, so stopped. The patient reported a transient right side paresthesia, so decided to pull the catheter and reposition. The catheter was at 12 cm at the touhy needle hub. The anesthesiologist made one attempt at pulling the catheter and felt a sudden "snap". The catheter had broken off inside the patient. Removed the needle and inspected the skin. The coiled wire was still in the patient, so pulled on it until it was removed. After inspecting the epidural catheter, it was cleanly broken at approximately 4 cm. After this, the anesthesiologist placed a new epidural catheter (easily inserted) at l4/5. Slowly dosed this catheter until the patient had relief of her labor pains. They had a long discussion with the patient and her husband about the retained catheter. After this, informed the charge nurse, recorded the reference number of the epidural kit, and called neurosurgery. The anesthesiologist spoke with neurosurgery- who recommended leaving it in place and monitoring; thinks it is unlikely to require any treatment. Pt had a successful vaginal delivery at 4 am and was easily able to move lower extremities in the morning. The second catheter was easily removed. Pt had an mri done and was seen by neurosurgery who continued to recommend no further treatment was indicated at this time. Plan to follow up as outpatient.
 
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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 Key10100828
MDR Text Key192669390
Report Number10100828
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 03/31/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number45-0299 REV. 100
Device Catalogue NumberA4134-17
Device Lot Number3922278
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/31/2020
Event Location Hospital
Date Report to Manufacturer05/29/2020
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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