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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX NR FIT EPIDURAL CONTINUOUS TRAY; CATHETER, CONDUCTION, ANESTHETIC
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SMITHS MEDICAL ASD, INC. PORTEX NR FIT EPIDURAL CONTINUOUS TRAY; CATHETER, CONDUCTION, ANESTHETIC Back to Search Results
Catalog Number NSE0218MJP
Device Problem Physical Resistance/Sticking (4012)
Patient Problem Insufficient Information (4580)
Event Date 10/30/2023
Event Type  malfunction  
Manufacturer Narrative
Other text: d4: udi section, expiration date and h4: manufacture date are unavailable based on the reported lot number.G5: 510k is blank, this catalog number is not sold in the united states.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
 
Event Description
It was reported that while in use with a patient, when passing the catheter through the needle, it gets stuck.Adverse effects are unknown.
 
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Brand Name
PORTEX NR FIT EPIDURAL CONTINUOUS TRAY
Type of Device
CATHETER, CONDUCTION, ANESTHETIC
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
10 bowman dr.
keene NH 03431
Manufacturer (Section G)
NULL
Manufacturer Contact
jim vegel
MDR Report Key18234224
MDR Text Key329381967
Report Number3012307300-2023-10848
Device Sequence Number1
Product Code BSO
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberNSE0218MJP
Device Lot Number230707
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2023
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/31/2023
Initial Date FDA Received11/29/2023
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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