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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 NCE6087JP
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2021
Event Type  malfunction  
Event Description
Information received a smiths medical pain management|portex kits other malfunctioned.Reported by customer that water escaped or leaked from the syringe when aspirating the water by syringe.No patient injury.
 
Manufacturer Narrative
Other text: one used sample was returned for analysis.A defect could be found on the wiper edge seal of the plunger tip rubber.A leakage was observed during both a liquid leakage test and the loss of resistance test.The defect in the plunger tip component was examined under magnification.The defect was indicative of a molding issue.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
 
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Brand Name
PORTEX
Type of Device
PAIN MANAGEMENT
MDR Report Key11829399
MDR Text Key250800245
Report Number3012307300-2021-04383
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 user facility
Type of Report Initial,Followup
Report Date 06/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberNCE6087JP
Device Lot Number210112
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2021
Was the Report Sent to FDA? No
Date Manufacturer Received05/25/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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