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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
Model Number NCE6552JP
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2021
Event Type  malfunction  
Event Description
Information received a smiths medical pain management|portex kits malfunctioned.Reported after indwelling the catheter in the patient, when the customer infused medical fluid through the catheter using a syringe, he found leakage from the connector.So he changed the connector to another new one, and after that, the product worked normally.No patient injury.
 
Manufacturer Narrative
Other, other text: one device was received for evaluation.Visual inspection confirmed that the hinge was broken on the connector.Due to 100% inspection during manufacturing for the connector prior to setting, root cause analysis determined the broken hinge most likely occured post-manufacture.It's possible the part actually broke during use, however timing could not be identified.Problem source was traced to product molding design.Dhr completed and no discrepancies or anomalies found.
 
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Brand Name
PORTEX
Type of Device
PAIN MANAGEMENT
MDR Report Key12294209
MDR Text Key265595944
Report Number3012307300-2021-08222
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 company representative,foreig
Type of Report Initial,Followup
Report Date 09/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberNCE6552JP
Device Catalogue NumberNCE6552JP
Device Lot Number201027
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2021
Was the Report Sent to FDA? No
Date Manufacturer Received08/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/15/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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