MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX TRACHEOSTOMY REPLACEMENT INNER CANNULA; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 526070

Device Problems Accessory Incompatible (1004); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2019

Event Type  malfunction  

Manufacturer Narrative

Related to mfrs (same patient, multiple cannula issues): 3012307300-2019-02854, 3012307300-2019-02852, 3012307300-2019-03577, 3012307300-2019-03578, 3012307300-2019-03579, 3012307300-2019-03580, 3012307300-2019-03581, 3012307300-2019-03582, 3012307300-2019-03584, 3012307300-2019-03585, 3012307300-2019-03586, 3012307300-2019-03587, 3012307300-2019-03588.Reporter stated they are a retired pediatric tracheostomy and ventilator nurse specialist.

Event Description

Information was received that a smiths medical portex tracheostomy replacement inner cannula would not latch into place immediately upon use.It was noted that the patient's daughter is a certified pediatric nurse and "she helped her out" at the time of the event.The reporter also stated the patient's tracheostomy tube "is changed monthly at doctor's order.We did not have to change it due to the cannula not snapping.The cannula was changed twice a day to decrease risk of infections and to maintain patency of the airway".Four routine tube change outs were completed since the start of the event to present time (july).The daughter reported they had the same problem of the cannulas not snapping even with a new tube.Subsequently, due to the reporter noting the patient had run low on a supply of cannulas, some cannulas had to be cleaned, boiled, and re-used.There were no adverse patient effects as a result of the event.

Manufacturer Narrative

Fourteen tracheostomy tubes were received for evaluation; seven samples were received in used condition, and seven in new condition.Visual inspection of the samples found them to be in good physical condition.Seven inner cannulas were inspected, and all were in specification, no discrepancies were found.Manufacturing was reviewed; line clearance record of inner cannula and the packaging process.Prior to packaging, a sample of 32 units was taken, in order to perform a visual inspection to verify for any damage with the inner cannula.No discrepancies were noted.The customer's reported complaint was unable to be confirmed.

• Brand Name: PORTEX TRACHEOSTOMY REPLACEMENT INNER CANNULA
• 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: 8809288
• MDR Text Key: 151701347
• Report Number: 3012307300-2019-03583
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 10351688041135
• UDI-Public: 10351688041135
• Combination Product (y/n): N
• PMA/PMN Number: K903730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/25/2024
• Device Model Number: 526070
• Device Catalogue Number: 526070
• Device Lot Number: 3754294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SMITHS MEDICAL PORTEX TRACHEOSTOMY TUBE