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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL PORTEX EPIDURAL CONTINUOUS TRAYS ANESTHESIA CONDUCTION KIT

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ST PAUL PORTEX EPIDURAL CONTINUOUS TRAYS ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 100/391/118CZ
Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/19/2020
Event Type  malfunction  
Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture. A product sample was received for evaluation. Visual and functional testing were performed. Upon visual inspection, there were used decontaminated components which are not part of claimed minipack plus one (1) flat filter was received for investigation without its original packaging. The technician noticed that the rotating collar (luer lock) is missing on returned filter. Each flat filter contains retention edge which is designed to hold rotating collar connected with filter. Retention edge on returned sample was found to be damaged and therefore it could not hold rotating collar in place. The root cause of the reported issue was found to be user overtightening the connection. Per information for use, "overtightening the connection between the catheter connector or epidural needle to the male rotating collar may cause rotating collar to dislodge from filter body. " unique identifier is unknown. No information has been provided to date. This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
 
Event Description
It was reported that the filter disconnected from the catheter. The end user did not have to change the catheter. This incident has been observed several times prior without being reported. No patient injury was reported.
 
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Brand NamePORTEX EPIDURAL CONTINUOUS TRAYS
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key15316110
MDR Text Key303433136
Report Number3012307300-2022-16612
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K965017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Pharmacist
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 Number100/391/118CZ
Device Lot Number4050193
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/11/2022
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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