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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PORTEX; PAIN MANAGEMENT
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PORTEX; PAIN MANAGEMENT Back to Search Results
Catalog Number 24-1301-22
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Information received a smiths medial pain management|portex epidural continuous trays markings no visible.The customer indicated they noticed the marking on the 18g epidural catheter was very faint in comparison to lure kits.On (b)(6) 2021: a form received and the customer responded that the outcome of the event pale markings on catheter make it harder for clinicians to use and less safe.
 
Manufacturer Narrative
Other text: one unit was returned for investigation.Visual inspection was done which confirmed the customer complaint of light markings on the device with root cause being traced to the manufacturer.The ink supplier was notified and have increased viscosity of the ink causing the markings to become darker in future.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.
 
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Brand Name
PORTEX
Type of Device
PAIN MANAGEMENT
MDR Report Key12374222
MDR Text Key268358683
Report Number3012307300-2021-08881
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 10/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number24-1301-22
Device Lot Number4095337
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2021
Was the Report Sent to FDA? No
Date Manufacturer Received09/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/22/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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