MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. TRACHEOSTOMY TUBE NEO/PED; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	67PFSS50
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that cuff of device was inflating asymmetrically and sticking to one side of the tube.Ifu suggested manipulation, but it was reported that did not work.The urgent trach change that was needed could not be carried out due to trach not inflating properly.No patient injury occurred.
Additional Manufacturer Narrative
Device evaluation- three samples were returned for evaluation.The devices were examined; this showed no damage to the cuffs, airline or pilot balloons.The devices were given functional testing to check for cuff function.Initially, for samples 1 and 3, the cuffs did not inflate symmetrically so the device cuffs were manually manipulated as per device instructions and after that the devices could be fully inflated and deflated with symmetrical cuffs.Sample 2 functioned as expected.The device was then checked for leakage: no leakage occurred.This device type is 100% tested for cuff symmetry and cuff leak during production.The reported issue was not confirmed during testing.

• Brand Name: TRACHEOSTOMY TUBE NEO/PED
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis, mn
• MDR Report Key: 10379240
• Report Number: 3012307300-2020-07933
• Device Sequence Number: 16868434
• Product Code: JOH
• UDI-Device Identifier: 10351688518712
• UDI-Public: 10351688518712
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 67PFSS50
• Device Catalogue Number: 67PFSS50
• Device Lot Number: 3472144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening