MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT; TRACHEOSTOMY TUBE

Catalog Number 100/563/080

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/21/2016

Event Type  malfunction  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

User facility reported that the device was in use for intubation of patient.The patient was sedated, paralyzed and ventilated on 100% oxygen during the intubation procedure.According to reporter, the tracheal tube introducer could not be threaded over the guiding catheter because the hole in the introducer was too small.The user located another kit and completed the intubation successfully.According to reporter, the patient had no adverse effects during the delay.

Manufacturer Narrative

One 8.0mm introducer and one guiding catheter for ultraperc were returned for investigation.Examination and testing of the guiding catheter for ultraperc, found no fault with the returned device.During functional testing of the introducer, a guiding catheter was inserted; however, the catheter was unable to go through the introducer.Upon further examination of the introducer, damage was found on the center section of the metal tube component.Additionally, the red dilator was found bent and the tube was found kinked.Investigation was unable to determine the root cause of the bend in the introducer; however, no evidence was found to suggest an intrinsic product issue.(b)(4).

Event Description

Additional information: according to the reporter, the reported event occurred during a percutaneous tracheostomy procedure.

• Brand Name: PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; 52 grayshill road; cumbernauld; glasgow, G68 9 HQ,; UK G68 9HQ,
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; 52 grayshill road; cumbernauld; glasgow, G68 9 HQ,; UK G68 9HQ,
• Manufacturer Contact: lisa perz ; 1265 grey fox rd.; st. paul, MN 55112 ; 7633833074
• MDR Report Key: 5817519
• MDR Text Key: 50303138
• Report Number: 2183502-2016-01615
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K041348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 100/563/080
• Device Lot Number: 3168103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1