MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA STANDARD UNCUFFED HYPERFLEX CUSTOM TRACHEOSTOMY TUBE

Catalog Number HU14JS40NSC085N

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2015

Event Type  malfunction  

Manufacturer Narrative

The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

It was reported that during inspection prior to use the wiring was found exposed and sticking out of the tube.A spare tracheostomy tube was used.No adverse health outcome resulted from this event.

Manufacturer Narrative

One tube was returned for evaluation.It was confirmed by visual inspection that the wire was exposed from the inside of the tube in the connector area.The exposed wire was determined to be due to a manufacturing error.Work instructions were reviewed and found to be adequate.A quality alert was issued to heighten the awareness of this issue with the operators.

• Brand Name: BIVONA STANDARD UNCUFFED HYPERFLEX CUSTOM TRACHEOSTOMY TUBE
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 w 23rd ave; gary IN 46406
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 w 23rd ave; gary IN 46406
• Manufacturer Contact: michele seliga ; 1265 grey fox rd; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 5169731
• MDR Text Key: 29007296
• Report Number: 2183502-2015-00792
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/22/2015

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: Health Professional
• Device Expiration Date: 09/24/2020
• Device Catalogue Number: HU14JS40NSC085N
• Device Lot Number: GS002543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/01/2015
• Initial Date FDA Received: 10/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2015
• 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