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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

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SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR) Back to Search Results
Model Number 100/810/080
Device Problems Break (1069); Crack (1135)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Date of event is unknown, no information has been provided to date.Investigation, including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
 
Event Description
It was reported that the cannula was showing cracks in the body of the sub cannula, making it unusable for the patient.In addition, the sub cannula for hygienization also breaks easily and prevents the replacement of the sub cannula when necessary.This is causing frequent exchange of cannulas.Customer reports that training is periodically provided for this material.A total of 6 complaints were created to document this report.
 
Manufacturer Narrative
Other, other text: h6.Event problem and evaluation codes: updated.Investigation of this complaint was limited because no sample was provided.Two (2) photos were provided where a crack of inner cannula across its length is visible.No trend of complaints related to inner cannula crack has been received.A device history record (dhr) review showed no discrepancies were reported during manufacturing for the reported lot number.The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined.
 
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Brand Name
PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE
Type of Device
TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
olomoucka 306
hranice 1, mesto 753 0 1
EZ  753 01
Manufacturer (Section G)
NULL
olomoucka 306
hranice 1, mesto 753 0 1
EZ   753 01
Manufacturer Contact
jim vegel
6000 nathan lane north
tambore ? santana de
minneapolis, MN 55442
MDR Report Key16432229
MDR Text Key310139396
Report Number3012307300-2023-01585
Device Sequence Number1
Product Code BTO
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K030381
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number100/810/080
Device Catalogue Number100/810/080CZ
Device Lot Number4034791
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/01/2023
Initial Date FDA Received02/23/2023
Supplement Dates Manufacturer Received03/02/2023
Supplement Dates FDA Received03/10/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/18/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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