MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® UNCUFFED PEDIATRIC FLEXTEND¿ PLUS SILICONE TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	60PFS40
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported on (b)(6) 2017 that the event occurred "about two weeks ago".The exact date is unknown.(b)(6).
Event or Problem Description
It was reported that the neck flange of a portex® bivona® uncuffed pediatric flextend¿ plus silicone tracheostomy tube broke.The fault was discovered when trying to perform a tracheostomy tube change.No injury was reported.
Additional Manufacturer Narrative
One medfusion® 3500 syringe pump was returned for investigation.A visual inspection revealed the pump to be in poor condition; the top case was cracked down from the handle, the right plunger case was broken, and the plunger head would not move.A review of the pump's event history log confirmed the reported issue.A mechanical inspection showed the plunger rod was not installed properly into the clutch cam, causing the plunger head not to move.The timing plates were not set properly in the plunger head.The root cause for the problem was determined to be that the pump was improperly assembled by the user.
Additional Manufacturer Narrative
One portex® bivona® uncuffed pediatric flextend¿ plus silicone tracheostomy tube was received for analysis in a (b)(6) bag and in a used condition.Visual inspection was performed at 12" under normal conditions of illumination in order to detect any damage on the part revealing that the flange to the left side of the tracheostomy (trach) was missing.Relevant documents were reviewed and considered adequate and correct for testing and inspection.A review of the manufacturing process was conducted on similar products from 05/oct/2017 to 09/oct/2017 in order to verify that there are no situations or practices that could create the event as described in the complaint.All procedures are being carried appropriate.The assembly process was performed according to the procedures listed above.The training was reviewed and it was confirmed that the personnel had the trainings up to date.Verification of 32 assemblies were reviewed for possible molding issues by visual aid with no damage detected.Based on the evidence, the probable root cause is that damaged occurred after the product left the manufacturing facility.

• Brand Name: PORTEX® BIVONA® UNCUFFED PEDIATRIC FLEXTEND¿ PLUS SILICONE TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6773740
• Report Number: 3012307300-2017-01713
• Device Sequence Number: 11013640
• Product Code: JOH
• UDI-Device Identifier: 15021312005868
• UDI-Public: 15021312005868
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2017

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
• Operator of Device: No Information
• Device Expiration Date: 05/25/2022
• Device Catalogue Number: 60PFS40
• Device Lot Number: 3420090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2017
• Supplement Date Received by Manufacturer: 11/22/2017; 11/22/2017
• Initial Report FDA Received Date: 08/08/2017
• Supplement Report FDA Received Date: 12/01/2017; 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1