MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TRACHEOSTOMY; NEONATAL/PEDIATRIC TRACHEOSTOMY

Model Number	67PFPS45
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during pre-test, the cuff was inflating asymmetrically.No patient involvement.
Additional Manufacturer Narrative
The sample was not received for investigation.The customer reported issue could not be confirmed due to no receipt of photos or actual sample for investigation.A device history record (dhr) review was performed which indicated all inspections were completed and no issues were noted during manufacture.Manufacturing controls are in place to help prevent occurrence of the reported issue.No root cause could be determined since no product and/or photos were received to investigate the reported issue.If the product is returned at a later, a summary of the investigation results will be provided in a supplemental report.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).

• Brand Name: BIVONA TRACHEOSTOMY
• Common Device Name: NEONATAL/PEDIATRIC TRACHEOSTOMY
• 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: 15409662
• Report Number: 3012307300-2022-18868
• Device Sequence Number: 20211886
• Product Code: JOH
• UDI-Device Identifier: 10351688518552
• UDI-Public: 10351688518552
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K923878
• 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
• Report Date (Section B): 09/13/2022

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 Expiration Date: 12/18/2024
• Device Model Number: 67PFPS45
• Device Catalogue Number: 67PFPS45
• Device Lot Number: 3760468
• 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: 07/08/2022
• Initial Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown