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

Model Number	67PFSS45
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device serial number/lot number were not communicated; device expiration date and device manufacturing date not available.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 after 2 times re-preparation of the trach, the cuff only fills up to one side.No injury reported.Additional information received via e-mail 14-oct-2022: patient location updated.The product is not returning for investigation due to the information that germs were detected with the patient, germs which have multi-resistance characteristics.Therefore, the photos in the attachments should be used instead.Additional information received via e-mail 04-nov-2022: lot number remains unknown.
Additional Manufacturer Narrative
Other text: h6: event problem and evaluation codes: updated.H10: no lot number was provided; therefore, device history record review could not be performed.Four photos were received for evaluation.Visual inspection found per photos received, could not confirm the asymmetry cuff as its necessary to measure the cuff concentricity to know if the cuff is within specification.No other analysis was performed.Root cause cannot be addressed since the cuff was inflated symmetrically.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken accordingly.This remediation mdr was generated under protocol (b)(4),as a result of warning letter cms# (b)(4).

• Brand Name: BIVONA TUBES NEO/PED FLEXTEND
• 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: 15733864
• Report Number: 3012307300-2022-26731
• Device Sequence Number: 6316595
• Product Code: JOH
• UDI-Device Identifier: 10351688518705
• UDI-Public: 10351688518705
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2023

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 Model Number: 67PFSS45
• Device Catalogue Number: 67PFSS45
• Was Device Available for Evaluation?: No
• 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: 10/12/2022
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 05/10/2023
• 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 Sex: Unknown