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

Model Number	67N035
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was received for evaluation in relation to the reported event.Evaluation of the device is currently in progress.Once the evaluation is complete, a follow-up report with evaluation results will be submitted.
Event or Problem Description
It was reported that during trach care with 2 nurses, trach tube dislodged.It was noticed that the balloon on the trach still had 2 ml of sterile water (as ordered) but the internal part was not inflating.There was no patient injury reported.
Additional Manufacturer Narrative
Additional information b5 d5 h6 this mdr was generated under protocol b10010116, as a result of warning letter 3012307300-2022-05701-1 (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.One sample was received in used conditions without original package.Sample was filled with 5 cubic centimeters (cc) of air according to procedure to see if there was any functional problem.When the sample was inflated with air, the cuff only inflated one side.According to the instruction for use (ifu), the pilot balloon was manipulated, and the cuff inflated.After the whole cuff inflated, it was deflated and inflated 4 times, all the time the cuff inflated completely and symmetrically, based on analysis the complaint is not confirmed.The root cause of the reported problem could not be determined since the sample successfully passed functional test.No corrective actions were taken since the complaint was not confirmed, corrected data: d1 g5.
Event or Problem Description
Additional information received via customer response email (b)(6) 2022: the reported issue did not cause or contribute to patient or clinical injury.

• 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: 13977265
• Report Number: 3012307300-2022-05701
• Device Sequence Number: 14812569
• Product Code: JOH
• UDI-Device Identifier: 15021312006223
• UDI-Public: 15021312006223
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2023

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: Health Professional
• Device Model Number: 67N035
• Device Catalogue Number: 67N035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2022
• 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: 03/03/2022
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 03/17/2023
• 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