MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX TUBES BLUE LINE CLASSIC; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/523/060

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device evaluation in progress.

Event Description

It was reported that after immediately opening the portex tubes blue line classic package, the customer noticed the adjustable flange was damaged.No death or serious injury was reported in connection with this incident.

Manufacturer Narrative

One tracheostomy was returned for evaluation, received in used conditions without its original packaging.The sample was visually inspected, and it was observed that the flange was damaged.Production performs a 100% visual inspection to ensure that the flange tape holes are free from cracks, breaks and are not occluded.The customer's complaint was verified.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: PORTEX TUBES BLUE LINE CLASSIC
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7916726
• MDR Text Key: 121993210
• Report Number: 3012307300-2018-04033
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/05/2023
• Device Catalogue Number: 100/523/060
• Device Lot Number: 3546339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2018
• Initial Date Manufacturer Received: 08/30/2018
• Initial Date FDA Received: 09/27/2018
• Supplement Dates Manufacturer Received: 10/05/2018
• Supplement Dates FDA Received: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1