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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC PORTEX COMBINED SPINAL EPIDURAL CSECURE TRAYS; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
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SMITHS MEDICAL ASD, INC PORTEX COMBINED SPINAL EPIDURAL CSECURE TRAYS; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) Back to Search Results
Catalog Number 100/491/718
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem Pain (1994)
Event Date 03/12/2019
Event Type  malfunction  
Event Description
It was reported that there was a noted leak /epifuse break leading to under management of pain during a surgical procedure; causing pain.No further complications were reported in relation to this complaint.
 
Manufacturer Narrative
One spinal epidural minipack was returned for evaluation.Visual inspection of the returned sample found it to be in good physical condition.Components returned were tested against the requirements of the purchase specifications and the inspection procedures and no issues were found.Additionally, the catheter connector was found to be performing as intended; customer complaint not confirmed.While no definitive problem source to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a cause of issue related to manufacturing.
 
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Brand Name
PORTEX COMBINED SPINAL EPIDURAL CSECURE TRAYS
Type of Device
NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC
6000 nathan lane north
minneapolis MN 55442
MDR Report Key8746945
MDR Text Key149711700
Report Number3012307300-2019-02964
Device Sequence Number1
Product Code BSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 10/07/2019
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 No Information
Device Expiration Date11/18/2021
Device Catalogue Number100/491/718
Device Lot Number3306906
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2019
Initial Date Manufacturer Received 06/05/2019
Initial Date FDA Received06/30/2019
Supplement Dates Manufacturer Received07/22/2019
Supplement Dates FDA Received10/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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