MAUDE Adverse Event Report: SMITHS MEDICAL INT'L LTD PORTEX NEONATAL PEDIATGRIC TRACHEAL TUBE HOLDER; JAY-SUPPORT, BREATHING TUBE

Catalog Number H4051

Device Problems Difficult to Insert (1316); Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

User facility reported difficulty passing the suction catheter through the tracheal tube holder.No permanent adverse effects to pt reported.

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device eval.When and if the device becomes available and is returned and evaluated, the manufacturer will file a f/u report detailing the results of the eval.

• Brand Name: PORTEX NEONATAL PEDIATGRIC TRACHEAL TUBE HOLDER
• Type of Device: JAY-SUPPORT, BREATHING TUBE
• Manufacturer (Section D): SMITHS MEDICAL INT'L LTD; hythe, kent
• Manufacturer (Section G): SMITHS MEDICAL INT'L LTD; boundary rd; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 4048021
• MDR Text Key: 19085218
• Report Number: 2183502-2014-00560
• Device Sequence Number: 1
• Product Code: JAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H4051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/05/2014
• Event Location: Hospital
• Date Manufacturer Received: 05/09/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PORTEX UNCUFFED NEONATAL/PEDIATRIC TRACHEAL TUBE