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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX REUSABLE SWIVEL CONNECTOR; TUBE TRACHEAL
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SMITHS MEDICAL ASD, INC. PORTEX REUSABLE SWIVEL CONNECTOR; TUBE TRACHEAL Back to Search Results
Model Number 3715293
Device Problem Blocked Connection (2888)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/31/2021
Event Type  malfunction  
Event Description
It was reported the device was being prepared for placement with patient.When opening the product, the user noted the suction port was stuck in the connector.Device not used with patient.No adverse effects reported.
 
Manufacturer Narrative
No device was returned for evaluation.No lot number provided, no dhr review able to be done.
 
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Brand Name
PORTEX REUSABLE SWIVEL CONNECTOR
Type of Device
TUBE TRACHEAL
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
jim vegel
6000 nathan lane north
westcliff on sea
minneapolis, MN 55442
MDR Report Key13471460
MDR Text Key285170502
Report Number3012307300-2022-02773
Device Sequence Number1
Product Code BZA
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3715293
Device Catalogue Number100/257/000
Device Lot Number3715293
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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