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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MMJ SA DE CV (USD) SHILEY; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

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MMJ SA DE CV (USD) SHILEY; TUBE, TRACHEOSTOMY (W/WO CONNECTOR) Back to Search Results
Model Number 137-80
Device Problem Disconnection (1171)
Patient Problem Death (1802)
Event Date 05/29/2019
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, tracheostomy was performed due to poor ventilation to the critically ill patient connected to mechanical ventilation.Premature dislodgement of the tracheostomy tube was observed after procedure, the tube was removed to be replaced but patient suffered cardiac arrest and died later on.After removing the tube, it was observed that the access to the trachea was not established, the tracheostomy tube was oriented against the right side of the trachea posterior wall, creating a false passage, resulting in loss of the airway.There was no difficulty experienced inserting the device and the tube was placed a few hours.Respirator was connected to the tube while it was in place.
 
Manufacturer Narrative
Evaluation summary: no sample was returned for evaluation.Review of the two photos shows a unit pack and the remaining photo shows a used unit.Review of the photo shows that the unit is contaminated.Further examination shows that the neck plate and the tubing are not perpendicular.As no sample has been returned it is impossible to confirm if this movement happened as a result of the locking mechanism.Analysis of the retain sample confirms that the lock nut was securely locked to the neck plate and no movement was noted along the main stem of the tubing.Visual examination of the lock nut and the neck plate shows no sign of any moulding issue.The internal diameter of the neck plate and lock nut of the retain sample was measured and found to be within the blueprint specifications.In the absence of the actual complaint sample it is not possible to determine the root cause of this particular issue.All of our flange and lock nuts components are injection moulded, during this moulding process the machine setter and quality controller carry out first piece inspection.During the first piece inspection the quality controller and the machine setter verify the specifications requirements of the locknuts and flange components, measure the components and record their findings.Periodically during the lot run roving inspections are carried out.It is at these stages of the injection moulding process that any issues are identified and removed from the lot.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
SHILEY
Type of Device
TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
Manufacturer (Section D)
MMJ SA DE CV (USD)
ave henequen no 1181 desarroll
ciudad juarez 32590
MX  32590
Manufacturer (Section G)
MMJ SA DE CV (USD)
ave henequen no 1181 desarroll
ciudad juarez 32590
MX   32590
Manufacturer Contact
avi kluger
5920 longbow drive
boulder, CO 80301
3035306582
MDR Report Key9122721
MDR Text Key160153454
Report Number2936999-2019-00792
Device Sequence Number1
Product Code BTO
UDI-Device Identifier30884522006709
UDI-Public30884522006709
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K884730
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number137-80
Device Catalogue Number137-80
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/02/2019
Initial Date FDA Received09/26/2019
Supplement Dates Manufacturer Received10/22/2019
Supplement Dates FDA Received11/20/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death; Required Intervention;
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