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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MMJ SA DE CV (USD) SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF
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MMJ SA DE CV (USD) SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF Back to Search Results
Model Number 4.0 PED
Medical Device Problem Codes Device Markings/Labelling Problem (2911); Device Packaging Compromised (2916)
Health Effect - Clinical Code Extubate (2402)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, the device had wrong tracheostomy tube inside the box, they found a size 6 tracheostomy tube inside the size 4 tracheostomy box.It was indicated that the unit was not sterile because the box was not sealed.It was also reported that the patient had a severe discomfort due to the larger size of the tube than the stoma site.The customer reported that they replaced the tube from size 6 to size to size 4.
 
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Brand Name
SHILEY
Common Device Name
TUBE TRACHEOSTOMY AND TUBE CUFF
Manufacturer (Section D)
MMJ SA DE CV (USD)
ave henequen no 1181 desarroll
ciudad juarez,ci 32590
MX  32590
MDR Report Key7645839
Report Number2936999-2018-00420
Device Sequence Number1651776
Product Code JOH
UDI-Device Identifier30884522026714
UDI-Public30884522026714
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K945513
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 06/28/2018
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
Operator of Device Health Professional
Device Model Number4.0 PED
Device Catalogue Number4.0 PED
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/13/2018
Initial Report FDA Received Date06/28/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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