MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA FLEXTEND PEDIATRIC NEONATAL TRACHEOSTROMY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	60PFSS40
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the end of the trach has deformity.The customer got it out of the box and inspected the tracheostomy tube and saw that the distal end of the tube looked kinked or irregular.The wire inside seem to be bent and not uniform.
Additional Manufacturer Narrative
Other text: d4: device serial number/lot number is unknown.H4: device manufacturing date could not be determined.H6: event problem and evaluation codes: updated.H10: no lot number was provided; therefore, device history record review could not be performed.A product sample and one photo was received for evaluation.Visual inspection of the photo and sample showed a deformation on tube tip.The root cause of the reported issue was found to be manufacturing mishandling during unload.Customer complaint notification was made to production personnel to explain the importance to adherence or following in the manufacturing procedure, by quality engineer on 18/jan/2023.This remediation mdr was generated under protocol b10010579, as a result of warning letter cms# 617147.

• Brand Name: BIVONA FLEXTEND PEDIATRIC NEONATAL TRACHEOSTROMY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15188592
• Report Number: 3012307300-2022-14995
• Device Sequence Number: 5603278
• Product Code: JOH
• UDI-Device Identifier: 15021312516784
• UDI-Public: 15021312516784
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2023

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: Other
• Device Model Number: 60PFSS40
• Device Catalogue Number: 60PFSS40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown