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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX SPINAL (SDD) 25G W/DRUGS ANESTHESIA CONDUCTION KIT

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SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX SPINAL (SDD) 25G W/DRUGS ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number NSE4100GCJP
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2020
Event Type  malfunction  
Event Description
It was reported that it was reported that during the use of the product, the epidural catheter got torn off. No patient injury was reported.
 
Manufacturer Narrative
No lot number was provided; therefore, device history record review could not be completed. A product sample was received for evaluation. Visual and functional testing were performed. As a result of observing the sample, it was confirmed that the catheter was broken and the catheter around the broken position was extended. When observed with a microscope, it was confirmed that the fracture surface was crushed into an elliptical shape, which closely resembled the trace of fracture caused by being sandwiched between sharp blades such as scissors. The root cause of the reported issue was found to be highly probable that the catheter was damaged due to contact with scissors during use. Udi is unknown. No product information has been provided to date. This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).
 
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Brand NamePORTEX SPINAL (SDD) 25G W/DRUGS
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT21 6JL
UK CT21 6JL
Manufacturer (Section G)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT21 6JL
UK CT21 6JL
Manufacturer Contact
jim vegel
6000 nathan lane north
akasaka, minato-ku, tokyo
minneapolis, MN 55442
MDR Report Key15316180
MDR Text Key300793539
Report Number3012307300-2022-16611
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K965017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/29/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNSE4100GCJP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2020
Was the Report Sent to FDA? No
Date Manufacturer Received05/23/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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