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

Model Number	67SP050
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was found with trach in hand, cuff side flange attached to trach, ties separated from stem/base of trach.
Additional Manufacturer Narrative
One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could not be duplicated.The device passed all functional tests.Dhr review was done, no issues related to the original complaint were found.
Additional Manufacturer Narrative
This mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.No problems or issues were identified during this device history record review.A product sample was received for evaluation.Visual and functional testing were performed.Two (2) sample were in used conditions, without its original packaging and with its certificate of safe handling.Visual inspection was performed at 12 inch under normal conditions of illumination per procedure.Sample 1: the damage is a break from mishandling, not a clean cut, you can see stress wear on the edge.Sample 2: the damage is a break from mishandling, not a clean cut, you can see stress wear on the edge.According to the complaint description, one of the devices was found in the hands of the patient, attributing that the device was in good condition for use, the second device is mentioned to have broken after use assuring that it was also in good condition.The complaint cannot be confirmed since it was caused by mishandling of the devices and could not have been produced during the manufacturing process.During neck strap molding process, it was tried to remove the unit from mold but bushing was stuck it, therefore, when it was tried to remove it, a split was created with the mold in the neck strap.The split was large and dept to the tube.Based on the test performed, it was concluded that failure reported could not be reproduced during the molding process since the cut created is not in the same position as sample received, the reproduced cut was deeper than cut from sample received.The root cause of the reported issue could not be confirmed as the reported issue could not be replicated at the time of the device evaluation.The damage probably occurred after the product left the manufacture.No corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process.

• Brand Name: BIVONA NEONATAL AND PEDIATRIC TTS
• Common Device Name: TRACHEOSTOMY TUBE AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13667035
• Report Number: 3012307300-2022-04291
• Device Sequence Number: 12131364
• Product Code: JOH
• UDI-Device Identifier: 15021312000740
• UDI-Public: 15021312000740
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2023

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: Lay User/Patient
• Device Expiration Date: 06/23/2026
• Device Model Number: 67SP050
• Device Catalogue Number: 67SP050
• Device Lot Number: 4161973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 04/07/2022; 02/03/2023
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 05/05/2022; 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2021
• 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