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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC LIMITED PEDIATRIC MAGILLE ENDOTRACHEAL TUBE 3.0MM POUCH, COLOSTOMY

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CONVATEC LIMITED PEDIATRIC MAGILLE ENDOTRACHEAL TUBE 3.0MM POUCH, COLOSTOMY Back to Search Results
Model Number 35111
Device Problem Inflation Problem (1310)
Patient Problems Aspiration/Inhalation (1725); Pneumonia (2011)
Event Type  Injury  
Manufacturer Narrative
Based on the available information, this event is deemed to be both a reportable malfunction and a serious injury. No lot number or product evaluation sample is available. A detailed investigation or batch review cannot be conducted. Therefore this evaluation will be closed and will be monitored through our post market product monitoring review process. Additional details have been requested but not provided to date. Should additional information become available, a follow-up report will be submitted. Reported to the fda on: november 01, 2016. (b)(4). Note: this complaint issue occurred in three (3) cases. A separate 3500a form has been prepared for the other two (2) associated cases.
 
Event Description
Complaint received reporting that the device cuff did not seal (inflate) and re-inflation was required every hour to maintain proper cuff pressure for an emergency intubation of a (b)(6) old patient. The device was removed and a new one inserted. The cuff on the second device also did not seal (inflate). Metal clamps were attached to the pilot tube to stabilize the airway cuff pressure. The second device was removed and a third device was inserted. The physician stated that this is not the first time this issue has occurred. However, it is unknown how many devices were affected. The patient's condition was critical during the event, but it could not be confirmed that the patient's condition worsened due to the reported event. It was reported that the patient required suction to clear aspirated fluid. It was also reported that the patient is stabilized and is recovering from aspiration pneumonia. The device is no longer available and was discarded. No further information has been provided.
 
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Brand NamePEDIATRIC MAGILLE ENDOTRACHEAL TUBE 3.0MM
Type of DevicePOUCH, COLOSTOMY
Manufacturer (Section D)
CONVATEC LIMITED
first avenue
deeside industrical park
deeside, flinshire CH52N U
UK CH52NU
Manufacturer Contact
jeanette johnson
7900 triad center drive
suite 400
greensboro, NC 27409
3365424681
MDR Report Key6071319
MDR Text Key58926771
Report Number9611710-2016-00146
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 10/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number35111
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/01/2016 Patient Sequence Number: 1
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