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

Model Number	60NFP40
Medical Device Problem Codes	Material Discolored (1170); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Distress (2329); Discomfort (2330)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: d4: lot number, expiration date, and h4: manufacture date are unknown, no information has been provided.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the parent contacted concerned that they had discovered a split in the tubing of a tracheostomy tube on removal from the child.The back up tracheostomy tube they were about to insert was also found to have an area that appeared similarly discolored.The plastic was discolored and may also have a micro split that was not visible.Reported to be found while in use with patient.No patient injury reported.The family had an extra spare tracheostomy tube.The child was able to tolerate a delay in the replacement of his tracheostomy tube.It was reported that the child was "upset/stressed and required additional support such as increased suctioning".A1: one patient, two product malfunctions.(b)(6) and (b)(6) both represent the same patient.
Additional Manufacturer Narrative
Other text: it has been determined that complaint file (b)(4) with a manufacturing report number of is a duplicate complaint entered in error.Please disregard the previous submission(s).Any additional reporting will be conducted under the applicable file.
Additional Manufacturer Narrative
Other text: b5 and h6.Evaluation codes: updated.No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review could not be performed as the lot number was unknown.If the product is returned the manufacturer will re-open the complaint for further device analysis.
Event or Problem Description
Additional information was received via email.It was noticed there was an increase in secretions and the patient has had a subsequent consultant review at the specialist center in which the tracheostomy brand was changed.

• Brand Name: BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACH TUBE
• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 17349403
• Report Number: 3012307300-2023-07222
• Device Sequence Number: 12084726
• Product Code: JOH
• UDI-Device Identifier: 15021312014747
• UDI-Public: 15021312014747
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2023

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: 60NFP40
• Device Catalogue Number: 60NFP40
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 07/13/2023; 08/09/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 08/07/2023; 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 10 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White