MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TUBES NEO/PED FLEXTEND; BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2022

Event Type  malfunction  

Manufacturer Narrative

Udi, device catalog number and serial number/lot are unknown.No information has been provided to date.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 Description

It was reported that the mother to an infant received their backup trach from the hospital they were discharged from and the trach broke into two pieces after being washed/reused 3 times.The mother also stated that the incident did occur while in the patient.

Manufacturer Narrative

H6: event problem and evaluation codes: updated.H10: no product was returned for investigation.The cause of the reported problem could not be determined, and the complaint cannot be confirmed.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.If the product is returned, the manufacturer will reopen this complaint for further investigation.No lot or serial number was provided therefore, a device history record (dhr) review could not be performed.This remediation mdr was generated under protocol b10010579, as a result of warning letter cms# (b)(4).

• Brand Name: BIVONA TUBES NEO/PED FLEXTEND
• Type of Device: BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC
• 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: 15882285
• MDR Text Key: 307705338
• Report Number: 3012307300-2022-27591
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 11/29/2022
• Supplement Dates Manufacturer Received: 06/12/2023
• Supplement Dates FDA Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 7 MO
• Patient Sex: Male
• Patient Weight: 7 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American, White