MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BLUE LINE ULTRA® SUCTIONAID®; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/860/085

Device Problems Decrease in Suction (1146); Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation in progress.

Event Description

It was reported that the customer was unable to draw bodily secretion through the cuff's upper suction line.No death or serious injury was reported in connection with this incident.

Manufacturer Narrative

One tracheostomy was returned for evaluation.A syringe was used to pass water through the suction line in order to check for occlusion.The reported customer's complaint was not confirmed.The water passed through the suction line, and it passed back, therefore suction line was not occluded.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: BLUE LINE ULTRA® SUCTIONAID®
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: dave halverson ; 1265 grey fox road; st. paul, MN 55112 ; 7633833310
• MDR Report Key: 7782504
• MDR Text Key: 117138613
• Report Number: 3012307300-2018-03217
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• PMA/PMN Number: K030570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 100/860/085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/18/2018
• 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: Unknown
• Patient Sequence Number: 1