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

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.

• Brand Name: PEDIATRIC MAGILLE ENDOTRACHEAL TUBE 3.0MM
• Type of Device: POUCH, 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 Key: 6071319
• MDR Text Key: 58926771
• Report Number: 9611710-2016-00146
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• 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 Received: 11/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 35111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 MO
• Patient Weight: 5