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

Model Number	67SP055
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An invalid lot number was provided; therefore, device history record review could not be completed.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection was performed at 12? under normal lighting to received unit, in order to detect any damage on the cuff, airline or pilot balloon.No damaged could be detected.Sample was filled with 5cc of air in order to see if there was any functional problem.When inflating the unit with air, it was seen that cuff inflated but a part was not uniformly.A review of the manufacturing process was conducted by quality engineer in order to verify that there are no situations or practices that could create the event as described.The root cause could not be determined.Operator of device is unknown.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.
Event or Problem Description
It was reported that the cuff was sticking to the shaft of the device.No patient injury was reported.

• Brand Name: BIVONA UNCUFFED NEONATAL AND PEDIATRIC FLEXTEND PL
• 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): 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: 15280289
• Report Number: 3012307300-2022-15960
• Device Sequence Number: 7166836
• Product Code: JOH
• UDI-Device Identifier: 15021312000757
• UDI-Public: 15021312000757
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2022

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
• Device Model Number: 67SP055
• Device Catalogue Number: 67SP055
• Device Lot Number: 2884258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• 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: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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