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

Model Number	67SP045
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the four cuffs were not inflating symmetrically with half the cuff sticking to the tube.No patient injury was reported.
Additional Manufacturer Narrative
Other, other text: a device history record (dhr) review was conducted which indicated all inspection were completed and no issues were noted during manufacture.Four samples were received without their original packaging inside a ziploc bag, in used conditions and with their certificate of safe handling.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.Results: no damaged could be detected.Functional test: air cuff symmetry test was performed to the units, leak testing and cuff symmetry visual aid.Cuff symmetry fixture was used.Results: when we inflated the sample 1, 2 and 3 with air, the cuff only inflate one side.The cuff was manipulated and the whole cuff inflated.After the whole cuff inflated, we deflated and inflated 4 times, all the times the cuff inflated completely.When we inflated the sample 4, the cuff inflated without problems.When we measured the cuffs, the percentage for the symmetry was for sample 1:44.44%, for sample 2:41.66%, for sample 3: 50% and for sample 4: 50%.These results are over 33.3% that is the minimum acceptable.Based on the test, the unit is within spec.The complaint is not confirmed.The following are relevant documents, which were reviewed and considered adequate and correct for testing and inspection activities.Based on the analysis conducted in the sample provided, the complaint was not confirmed.No corrective actions were taken since the complaint was not confirmed.D5 and g4 are unknown.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.

• Brand Name: BIVONA
• 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: 15466893
• Report Number: 3012307300-2022-20141
• Device Sequence Number: 7011215
• Product Code: JOH
• UDI-Device Identifier: 15021312000733
• UDI-Public: 15021312000733
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2022

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 Expiration Date: 07/03/2022
• Device Model Number: 67SP045
• Device Catalogue Number: 67SP045
• Device Lot Number: 3450063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2017
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown