MAUDE Adverse Event Report: SMITHS MEDICAL ASD,INC. TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	TRACH DIC CUF FEN 6.0MM + 1/EA
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product to be returned.The product was packaged (b)(6) 2019 on alloyd 2.Dhr's review found no discrepancies or anomalies relevant to the complaint.In-process, product was inspected for leakage and no non-conformities were noted.Incoming records review for cuff component cp370 (lot # 3859259) found no issues relevant to the complaint.
Event or Problem Description
Information received a smith medical tracheostomy|pvc - portex tubes dic required change out before the four weeks of use and scheduled change out.The reason reported was the tracheostomy has a leak.The reported indicated that this occurred a total of three events requiring change out with a certain 3865716 lot.No patient adverse events reported.

• Brand Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD,INC.; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9869268
• Report Number: 3012307300-2020-02198
• Device Sequence Number: 596097
• Product Code: JOH
• UDI-Device Identifier: 10351688001481
• UDI-Public: 10351688001481
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K934465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2020

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: Lay User/Patient
• Device Expiration Date: 04/30/2024
• Device Model Number: TRACH DIC CUF FEN 6.0MM + 1/EA
• Device Catalogue Number: 513060
• Device Lot Number: 3865716
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 03/23/2020
• 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: Required Intervention